Posts Tagged Randomized controlled trial

[ARTICLE] Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial

Abstract

Background and Purpose: After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy.

Methods: In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation.

Results: One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference −0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences.

Discussion and Conclusions: Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).

INTRODUCTION

Only 12% of stroke survivors obtain complete upper limb (UL) functional recovery after 6 months from stroke.1 In the remaining 88%, UL motor deficits persist with a negative impact on their level of activities2–4 and participation,5 according to the International Classification of Functioning, Disability and Health (ICF).6

Robotic therapy has been proposed as a viable approach for the rehabilitation of the UL, as a way to increase the amount and intensity of the therapy,7 and to standardize the treatment,8 by providing complex but controlled multisensory stimulation.7 Moreover, because of their built-in technology in terms of sensors and actuators, robotic devices can provide quantitative measure about the user’s dexterity.9 A large number of scientific articles on robot-assisted rehabilitation after stroke have been published, analyzing the effects of robotics alone,10–18 or in conjunction with conventional therapy.19–24 Nowadays, the use of robotic rehabilitation in addition to conventional therapy is recommended in some of the current stroke guidelines.25

Regarding the efficacy of robotic rehabilitation when compared with other treatments, the available scientific data are not conclusive. In comparing robotic and conventional treatment, some studies did not find an overall significant effect in favor of robotic therapy11,26,27: others showed a greater effect of robotic therapy than conventional therapy.28 However, in the latter case, the results must be interpreted with caution because the quality of the evidence was low or very low, owing to the variations between the trials in intensity, duration, and amount of training, type of treatment, participant characteristics, and measurements used. Finally, according to the most recent meta-analysis,29 it is not clear whether the difference between robotic therapy and other interventions (as conventional therapy) is clinically meaningful for the persons with stroke.

Almost all studies of robotic therapy have focused on the effects of the use of 1 device, compared with a conventional therapy approach. However, despite the complexity of the anatomy and the motor function of whole UL, especially the hand, almost all commercial devices act on a limited number of joints and a limited workspace. Conversely, during conventional therapy, the whole UL is routinely treated and the 3-dimensional space explored. Because of this, it is very difficult to compare the effects of 1 robotic device with conventional approaches. Therefore, it would be desirable to use devices that allow treatment of the entire UL (from shoulder to hand), in a workspace similar to that required in daily activities. Moreover, using more than 1 device new personnel organizational models can be adopted, wherein 1 physical therapist supervises more than 1 patient, thereby increasing the sustainability of the treatment.15,21,30

The aim of the current study was to evaluate, in subjects with subacute stroke, the efficacy of standardized UL robotic rehabilitation (using an organizational model in which 1 physical therapist supervises 3 subjects, each treated using a set of 4 robots and sensor-based devices), compared with UL conventional therapy. Outcomes of interest were selected to reflect effects on function, activities, and participation (per the ICF) […]

Continue —->  Upper Limb Robotic Rehabilitation After Stroke: A Multicente… : Journal of Neurologic Physical Therapy

 

, , , , , , ,

Leave a comment

[Abstract] Exploratory Randomized Double-Blind Placebo-Controlled Trial of Botulinum Therapy on Grasp Release After Stroke (PrOMBiS)

Background. OnabotulinumtoxinA injections improve upper-limb spasticity after stroke, but their effect on arm function remains uncertain.

Objective. To determine whether a single treatment with onabotulinumtoxinA injections combined with upper-limb physiotherapy improves grasp release compared with physiotherapy alone after stroke.

Methods. A total of 28 patients, at least 1 month poststroke, were randomized to receive either onabotulinumtoxinA or placebo injections to the affected upper limb followed by standardized upper-limb physiotherapy (10 sessions over 4 weeks). The primary outcome was time to release grasp during a functionally relevant standardized task. Secondary outcomes included measures of wrist and finger spasticity and strength using a customized servomotor, clinical assessments of stiffness (modified Ashworth Scale), arm function (Action Research Arm Test [ARAT], Nine Hole Peg Test), arm use (Arm Measure of Activity), Goal Attainment Scale, and quality of life (EQ5D).

Results. There was no significant difference between treatment groups in grasp release time 5 weeks post injection (placebo median = 3.0 s, treatment median = 2.0 s; t(24) = 1.20; P = .24; treatment effect = −0.44, 95% CI = −1.19 to 0.31). None of the secondary measures passed significance after correcting for multiple comparisons. Both groups achieved their treatment goals (placebo = 65%; treatment = 71%), and made improvements on the ARAT (placebo +3, treatment +5) and in active wrist extension (placebo +9°, treatment +11°).

Conclusions. In this group of stroke patients with mild to moderate spastic hemiparesis, a single treatment with onabotulinumtoxinA did not augment the improvements seen in grasp release time after a standardized upper-limb physiotherapy program.

 

via Exploratory Randomized Double-Blind Placebo-Controlled Trial of Botulinum Therapy on Grasp Release After Stroke (PrOMBiS) 

, , , , , , , , , ,

Leave a comment

[Abstract + References] Upper-Limb Exoskeletons for Stroke Rehabilitation – Conference paper

Abstract

Upper-limb exoskeletons provide high-intensity, repetitive, task-specific, interactive and individualized training, making effective use of neuroplasticity for functional recovery in neurological patients. Most exoskeletons have robot axes aligned with the anatomical axes of the subject and provide direct control of individual joints. Recently, novel mechanical structures and actuation mechanisms have been proposed, but still result in bulky and heavy exoskeletons, limiting their applicability into clinical practice. Technological efforts are needed to promote light and wearable exoskeletons that implement active-assistive controllers, providing “assisted-as-needed” rehabilitation therapy, towards patient’s motivation and self-esteem. An overview of upper-limb exoskeletons, including mechanical design and control algorithms, will be provided. Special focus will be put on the current evidence about the efficacy of wearable robotic technologies on motor recovery and about other therapies that can be combined with exoskeletons to improve their therapeutic effects.

References

  1. 1.
    Ambrosini, E., et al.: A myocontrolled neuroprosthesis integrated with a passive exoskeleton to support upper limb activities. J. Electromyogr. Kinesiol. 24(2), 307–317 (2014). Official Journal of the International Society of Electrophysiological KinesiologyGoogle Scholar
  2. 2.
    Basteris, A., et al.: Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J. NeuroEng. Rehabil. 11(1), 111 (2014)Google Scholar
  3. 3.
    Bertani, R., et al.: Effects of robot-assisted upper limb rehabilitation in stroke patients: a systematic review with meta-analysis. Neurol. Sci. 38(9), 1561–1569 (2017)Google Scholar
  4. 4.
    Calanca, A., et al.: A review of algorithms for compliant control of stiff and fixed-compliance robots. IEEE/ASME Trans. Mechatron. 21(2), 613–624 (2016)Google Scholar
  5. 5.
    Chang, W.H., Kim, Y.-H.: Robot-assisted therapy in stroke rehabilitation. J. Stroke 15(3), 174–181 (2013)Google Scholar
  6. 6.
    Gandolla, M., et al.: The neural correlates of long-term carryover following functional electrical stimulation for stroke. Neural Plast. 2016, 1–13 (2016)Google Scholar
  7. 7.
    Grimm, F., et al.: Closed-loop task difficulty adaptation during virtual reality reach-to-grasp training assisted with an exoskeleton for stroke rehabilitation. Front. Neurosci. 10, 518 (2016)Google Scholar
  8. 8.
    Howlett, O.A., et al.: Functional electrical stimulation improves activity after stroke: a systematic review with meta-analysis. Arch. Phys. Med. Rehabil. 96(5), 934–943 (2015)Google Scholar
  9. 9.
    Immick, N., et al.: Hybrid robotic system for arm training after stroke: preliminary results of a randomized controlled trial. In: International Conference on NeuroRehabilitation, pp. 94–97 (2019)Google Scholar
  10. 10.
    Islam, M.R., et al.: A brief review on robotic exoskeletons for upper extremity rehabilitation to find the gap between research prototype and commercial type. Adv. Robot. Autom. 06(03), 1–12 (2018)Google Scholar
  11. 11.
    Kim, B., Deshpande, A.D.: An upper-body rehabilitation exoskeleton Harmony with an anatomical shoulder mechanism: Design, modeling, control, and performance evaluation. Int. J. Robot. Res. 36(4), 414–435 (2017)Google Scholar
  12. 12.
    Krebs, H.I., et al.: Robot-aided neurorehabilitation: a robot for wrist rehabilitation. IEEE Trans. Neural Syst. Rehabil. Eng. 15(3), 327–335 (2007)Google Scholar
  13. 13.
    Langhorne, P., et al.: Motor recovery after stroke: a systematic review. Lancet Neurol. 8(8), 741–754 (2009)Google Scholar
  14. 14.
    Laver, K.E., et al.: Virtual reality for stroke rehabilitation. In: Laver, K.E. (ed.) Cochrane Database of Systematic Reviews. Wiley, Chichester (2011)Google Scholar
  15. 15.
    Lawrence, E.S., et al.: Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke 32(6), 1279–1284 (2001)Google Scholar
  16. 16.
    Lo, H.S., Xie, S.Q.: Exoskeleton robots for upper-limb rehabilitation: state of the art and future prospects. Med. Eng. Phys. 34(3), 261–268 (2012)Google Scholar
  17. 17.
    Mazzoleni, S., et al.: Combining upper limb robotic rehabilitation with other therapeutic approaches after stroke: current status, rationale, and challenges. BioMed Res. Int. 2017, 1–11 (2017)Google Scholar
  18. 18.
    Meadmore, K.L., et al.: Functional electrical stimulation mediated by iterative learning control and 3D robotics reduces motor impairment in chronic stroke. J. Neuroeng. Rehabil. 9, 32 (2012)Google Scholar
  19. 19.
    Mehrholz, J., et al.: Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst. Rev. (11), CD006876 (2015)Google Scholar
  20. 20.
    Nef, T., et al.: ARMin III – arm therapy exoskeleton with an ergonomic shoulder actuation. Appl. Bionics Biomech. 6(2), 127–142 (2009)Google Scholar
  21. 21.
    Pedrocchi, A., et al.: MUNDUS project: Multimodal Neuroprosthesis for Daily Upper limb Support. J. NeuroEng. Rehabil. 10(1), 66 (2013)Google Scholar
  22. 22.
    Pirondini, E., et al.: Evaluation of the effects of the arm light exoskeleton on movement execution and muscle activities: a pilot study on healthy subjects. J. NeuroEng. Rehabil. 13(1), 1–21 (2016)Google Scholar
  23. 23.
    Proietti, T., et al.: Upper-limb robotic exoskeletons for neurorehabilitation: a review on control strategies. IEEE Rev. Biomed. Eng. 9, 4–14 (2016)Google Scholar
  24. 24.
    Qian, Q., et al.: Early stroke rehabilitation of the upper limb assisted with an electromyography-driven neuromuscular electrical stimulation-robotic arm. Front. Neurol. 8, 447 (2017)Google Scholar
  25. 25.
    Rong, W., et al.: A Neuromuscular Electrical Stimulation (NMES) and robot hybrid system for multi-joint coordinated upper limb rehabilitation after stroke. J. NeuroEng. Rehabil. 14(1), 34 (2017)Google Scholar
  26. 26.
    Sensinger, J.W., Weir, R.F.F.: Improvements to series elastic actuators. In: Proceedings of the 2nd IEEE/ASME International Conference on Mechatronic and Embedded Systems and Applications, MESA 2006 (2007)Google Scholar
  27. 27.
    Stienen, A.H.A., et al.: Self-aligning exoskeleton axes through decoupling of joint rotations and translations. IEEE Trans. Rob. 25(3), 628–633 (2009)Google Scholar
  28. 28.
    Veerbeek, J.M., et al.: Effects of robot-assisted therapy for the upper limb after stroke. Neurorehabil. Neural Repair 31(2), 107–121 (2017)Google Scholar
  29. 29.
    Zhang, C., et al.: Robotic approaches for the rehabilitation of upper limb recovery after stroke. Int. J. Rehabil. Res. 40(1), 19–28 (2017)Google Scholar

via Upper-Limb Exoskeletons for Stroke Rehabilitation | SpringerLink

, , , , , , , , ,

Leave a comment

[Abstract] Effects of Exergame on Patients’ Balance and Upper Limb Motor Function after Stroke: A Randomized Controlled Trial.

Abstract

BACKGROUND:

Stroke is a major cause of motor incapacity in adults and the elderly population, requiring effective interventions capable of contributing to rehabilitation. Different interventions such as use of exergames are being adopted in the motor rehabilitation and balance area, as they act as motivating instruments, making therapies more pleasurable.

OBJECTIVE:

The aim of this study was to investigate the effects of exergame on patients’ balance and upper limb motor function after stroke.

METHODS:

This study is a randomized controlled trial. Thirty-one participants of both genders, mean age of 76 years, were assigned to the experimental or control groups; the experimental group (n = 16) underwent exergame rehabilitation using Motion Rehab AVE 3D, and the control group (n = 15) underwent conventional physiotherapy. Both EG and GC sessions happened twice a week, for 30 minutes each, over a 12 weeks period, resulting in 24 sessions. All sessions were composed of similar exercises, with same purpose and elapsed time (5 minutes). Instruments applied to verify inclusion criteria were a sociodemographic questionnaire and clinical aspects and a Mini-Mental State Examination. At baseline and after 12 weeks of intervention, the Modified Ashworth Scale, the Fugl-Meyer Assessment, and the Berg Balance Scale were used.

RESULTS:

In both groups, patients obtained significant improvement from baseline values in all analyzed variables (shoulder, elbow, and forearm; wrist; hand; and balance) (P < .001). In the intergroup comparison, there were significant differences between the 2 groups for changes in values from preintervention to postintervention of shoulder, elbow and forearm (P = .001), and total (P = .002).

CONCLUSION:

Exergame rehabilitation in poststroke patients can be an efficient alternative for restoring balance and upper limb motor function and might even reduce treatment time.

via Effects of Exergame on Patients’ Balance and Upper Limb Motor Function after Stroke: A Randomized Controlled Trial. – PubMed – NCBI

, , , , , , , , ,

Leave a comment

[Abstract] Rehabilitation of stroke patients with plegic hands: Randomized controlled trial of expanded Constraint-Induced Movement therapy

via Rehabilitation of stroke patients with plegic hands: Randomized controlled trial of expanded Constraint-Induced Movement therapy – IOS Press

, , , , , , , , , , ,

Leave a comment

[Abstract] Home-based tele-rehabilitation presents comparable and positive impact on self-reported functional outcomes as center-based rehabilitation: Singapore tele-technology aided rehabilitation in stroke (STARS) trial

Introduction/Background
Stroke is a leading cause of disability worldwide. Functional, financial and social barriers commonly prevent individuals with acute stroke and disabilities from receiving rehabilitation following their hospital discharge. Home-based rehabilitation is an alternative to center-based rehabilitation but it is often costlier. Tele-rehabilitation is a promising solution for optimizing rehabilitation utilization, as it can enable clinicians to supervise patients and conversely, patients to receive the recommended care remotely. Our team therefore developed a novel tele-rehabilitation, with the primary aim to estimate the extent to which the proposed tele-rehabilitation resulted in an improvement in function during the first three-months after stroke in comparison to usual rehabilitation.

Material and method
This was a randomized controlled trial. We used the Late-Life Function and Disability Instrument (FDI) to assess our primary outcome (with adjustment made for baseline covariate).

Results
We recruited 124 participants and randomized them to receive either 12-week home-based tele-rehabilitation or usual rehabilitation.

Rehabilitation
Over the 12-week rehabilitation period, the intervention group spent 2246-minutes on their rehabilitation whereas the control group spent 2565-minutes. The median difference between the two groups was not statistically significant (P = 0.649).

Primary Outcome (FDI)
The mean FDI frequency score post-rehabilitation for the intervention and control groups were 39.7 (SD 11.7) and 43.0 (SD 10.6) respectively. The mean FDI limitation score post-rehabilitation for the intervention group was 78.5 (SD 20.6) and that for the control group was 85.4 (SD 19.6). The unadjusted and adjusted differences in both FDI scores between the two groups were not statistically significant (Models 1 and 2).

Conclusion
Both groups reported comparable amount of time spent on rehabilitation and similarly positive impact on the primary outcome. Home-based tele-rehabilitation can be an effective strategy for minimizing or eliminating rehabilitation utilization barriers while achieving the same functional outcome as center-based rehabilitation.

via Home-based tele-rehabilitation presents comparable and positive impact on self-reported functional outcomes as center-based rehabilitation: Singapore tele-technology aided rehabilitation in stroke (STARS) trial – ScienceDirect

, , , ,

Leave a comment

[Abstract] Does adapted physical activity‑based rehabilitation improve mental and physical functioning? A randomized trial

BACKGROUND: Persons with chronic disabilities face a wide variety of problems with functioning that affect their level of physical activity and participation. We have limited knowledge about the effect of adapted physical activity (APA)-based rehabilitation on perceived mental and physical functioning.
AIM: The main aim of this study was to evaluate the effect of APA‑based rehabilitation compared to waiting‑list on perceived mental and physical functioning. Secondly, we wanted to assess whether improvement in self‑efficacy, motivation, pain and fatigue during rehabilitation was related to the effect of the intervention.
DESIGN: Randomized controlled trial.
SETTING: In‑patient rehabilitation Center.
POPULATION: All subjects above 17 years who were referred by their physician to BHC between July 1, 2010 and August 1, 2012 without major cognitive or language problems were eligible for the study (N.=321).
METHODS: Persons above 17 years (men and women) with chronic disabilities who applied for a rehabilitation stay, were randomized to an adapted physical activity‑based rehabilitation intervention (N.=304) or waiting‑list with delayed rehabilitation. A total of 246 consented and were allocated to four week intervention or a waiting‑list control group. The main outcome was physical and mental functioning evaluated four weeks after rehabilitation using the Medical Outcomes Study 12-Item Short‑Form Health Survey (SF-12).
RESULTS: Compared to waiting‑list the adapted physical activity‑based intervention improved physical and mental functioning. Improvement in physical functioning during rehabilitation was related to reduced pain, improved motivation and self‑efficacy.
CONCLUSIONS: The results indicate that an adapted physical activity‑based rehabilitation program improves functioning. Improved efficacy for managing disability may mediate the improvement in mental functioning.
CLINICAL REHABILITATION IMPACT: Adapted physical activity‑based rehabilitation should be considered during the development of rehabilitation strategies for people with chronic disabilities. Motivational and self‑efficacy aspects must be addressed when organizing and evaluating rehabilitation programs.

via Does adapted physical activity‑based rehabilitation improve mental and physical functioning? A randomized trial – European Journal of Physical and Rehabilitation Medicine 2018 June;54(3):419-27 – Minerva Medica – Journals

, , , , , , ,

Leave a comment

[ARTICLE] A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial – Full Text

Abstract

Background

Stroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform (“Guttmann, NeuroPersonalTrainer”®, GNPT®).

Methods/design

Individuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions.

Discussion

Customized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.

Background

Stroke, the most common cerebrovascular disease, is a focal neurological disorder of abrupt development due to a pathological process in blood vessels [1]. There are three main types of stroke, namely transient ischemic attack, characterized by a loss of blood flow in the brain and which reverts in less than 24 h without associated acute infarction [2]; ischemic stroke, characterized by a lack of blood reaching part of the brain due to the obstruction of blood vessels and causing tissue damage (infarction), wherein cells die in the immediate area and those surrounding the infarction area are at risk; and a hemorrhagic stroke, where either a brain aneurysm bursts or a weakened blood vessel leaks, resulting in blood spillage into or around the brain, creating swelling and pressure, and damaging cells and tissue in the brain [3].

In 2013, according to the World Health Organization (WHO) and the Global Burden of Disease study, worldwide, there were 11–15 million people affected by stroke and almost 1.5 million deaths from this cerebrovascular disease [45]. Moreover, in 2013, the total Disability-Adjusted Life Years (years of healthy life lost while living with a poor health condition) from all strokes was 51,429,440. In Spain, in 2011, the National Institute of Statistics reported 116,017 cases of stroke, corresponding to an incidence of 252 episodes per 100,000 inhabitants [6]. Although stroke incidence increases with advancing age, adults aged 20–64 years comprise 31% of the total global incidence.

Stroke often results in cognitive dysfunction, and medical treatment may cause great expense on a personal, family, economic, and social level. Depending on the area of the brain affected and the severity of lesions, stroke patients may suffer cognitive impairment, and alteration in emotional and behavioral regulation [7]. Generally, cognitive impairment derived from stroke includes alterations in attention, memory, and executive function [8].

Recent reports have begun to show positive results from the use of computerized cognitive rehabilitation systems (CCRS) for stroke patients to improve attention, memory, and executive functions. Nevertheless, more research is needed to better control variables and improve training designs in order to reduce heterogeneity and increase control of the intensity and level of performance during treatments [9101112].

CCRS allow adjustment of the type of exercises administered to the specific cognitive impairment profile of each patient, but within a fixed set of possible exercises such that heterogeneity of therapy choice is minimized. This can improve studies by allowing better categorization of patient groups that execute similar training sessions in a similar range of responses [13]. Further, CCRS offers the possibility of applying cognitive rehabilitation at home, while patient adherence and performance can be monitored online, so that patients do not need to live near, lodge near, or travel to a rehabilitation center to receive therapy. Because CCRS therapy is entirely digitized, it generates objective data that can be analyzed to determine the relative effectiveness of these interventions. We hypothesize that by allowing a trained professional to oversee an automated customization program that stratifies the level of difficulty, duration, and stimulus speed of presentation, we will reduce the heterogeneity of traditional cognitive training and improve the efficacy of intervention in chronic stroke patients.

The first objective of this pilot study is to assess if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform (“Guttmann, NeuroPersonalTrainer”®, GNPT ® ) [14] intended to increase the control of experimental variables (cognitive impairment profile, adherence, and performance) traditionally identified as a source of experimental heterogeneity. The study aims to assess if this benefit could translate into an improvement of the trained cognitive domains (attention, memory, and executive functions).

The second objective is focused on generalization, namely the ability to use what has been learned in rehabilitation contexts and apply it in different environments [15]. Transfer of learning is included within the concept of generalization when specifically referring to the ability to apply specific strategies to related tasks [16]. Two types of transfer have been proposed – near transfer and far transfer [17]. By near transfer we mean that, through the training of a task within a given cognitive domain, improved function in other similar, untrained tasks may be observed in the same cognitive domain. For instance, a patient who performs selective attention exercises and improves execution through the training might improve their performance in other selective attention exercises too. By far transfer we mean that training in a given cognitive domain may improve performance of tasks in other cognitive domains. Such improvement will be observable in tasks that are structurally dissimilar from the ones used in the training. For instance, if a patient performs selective attention exercises, they may also improve their performance in memory tasks.

It has been demonstrated that computerized cognitive training can lead to the phenomenon of transfer, as previously studied in stroke patients [18]. Thus, our research aims to note whether the application of patient-customized tele-rehabilitation can give rise to an improvement in other functions that are based on cognitive domains related to those that have been trained (near transfer) as well as in different ones (far transfer).

Finally, the third objective is to assess the variables of demography (age, sex, years of education) and etiology (ischemic stroke or hemorrhage) and their impact on rehabilitation outcome, given the need to understand the patient characteristics that may influence treatment effectiveness [19].[…]

 

Continue —> A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial | Trials | Full Text

 

Fig. 4Sham intervention (ictus.online) screenshots. a To access to the platform, the user must enter their username and password. b Each exercise begins with an instruction screen. c The user watches a 10-min video. d When finished, the user accesses a three-question quiz with four response options. e When the quiz is finished, a results screen is displayed. In each session, three videos with their corresponding quiz are presented

, , , , , , ,

Leave a comment

[ARTICLE] Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis – Full Text

 

Abstract

Background

Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined.

Methods

This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL).

Discussion

This multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation.

Background

Clinical practice guidelines recommend outpatient rehabilitation for stroke survivors who remain disabled after discharge from inpatient rehabilitation [1]. Although these guidelines recommend that the majority of stroke survivors receive at least some outpatient rehabilitation [2], many cannot access long-term care [3]. Among those individuals who do undergo outpatient rehabilitation, the standard of care for upper extremity rehabilitation is suboptimal.

In an observational study of 312 rehabilitation sessions (83 occupational and physical therapists at 7 rehabilitation sites), Lang and colleagues [4] found that functional rehabilitation (i.e., movement that accomplishes a functional task, such as eating, as opposed to strength training or passive movement) was provided in only 51% of the sessions of upper extremity rehabilitation, with only 45 repetitions per session on average. This is concerning given that empirically-validated interventions incorporate higher doses of active motor practice [5, 6, 7]. Additionally, functional upper extremity movements are most likely to generalize to everyday tasks [8], an aspect of recovery that is critically important to patients and their families [9, 10, 11]. Yet, passive movement and non-goal-directed exercise are more frequently administered [4].

There appear to be at least two critical elements required for successful upper extremity motor rehabilitation: 1) motor practice that is sufficiently intense and 2) techniques to carryover motor improvements to functional activities. Carry-over techniques to increase a person’s use of the more affected upper extremity for daily activities are extremely important for rehabilitation and appear necessary for structural brain change [12, 13, 14, 15]. When rehabilitation incorporates these techniques, there is substantially improved improvement in self-perceived quality of arm use for daily activities [12, 16]. Carry-over techniques enable the patient to overcome the conditioned suppression of movement (learned nonuse) characteristic of chronic hemiparesis [17]. Techniques include structured self-monitoring, a treatment contract, daily home practice of specific functional motor skills, and guided problem-solving to overcome perceived barriers to using the extremity [18].

Constraint-Induced Movement therapy (CI therapy) has strong empirical backing [5, 19] and combines high-repetition functional practice of the more affected arm with behavioral techniques to enhance carry-over [13, 18]. CI therapy produces consistently superior motor performance and retention of gains versus standard upper extremity rehabilitation [20, 21], particularly when it includes the critically important carry-over (transfer package) techniques [12]. When compared to other equally intensive interventions (i.e., equal hours of training on functional tasks), CI therapy with carry-over (transfer package) techniques has also shown enhanced carry-over of clinical gains to daily activities [12, 13, 22, 23, 24] that are retained for at least 2 years [19, 25, 26, 27, 28].

Despite its inclusion in best practice recommendations [29, 30], CI therapy is available to only a very small minority of those who could benefit from it in the US. CI therapy is not typically covered by insurance and the 30+ hours of assessment and physical training cost upwards of $6000. Access barriers for the patient include limited transportation and insurance coverage, whereas therapists may have difficulty accommodating the CI therapy schedule [31, 32]. Access barriers aside, CI therapy has also been plagued by a variety of misconceptions regarding use of restraint and the transfer package. Most iterations of CI therapy employ use of a restraint mitt to promote use of the affected arm, which is viewed by many patients and clinicians as excessively prohibitive [32]. Yet, literature demonstrates that restraint is not specifically required to achieve positive outcomes [33, 34]. Moreover, the transfer package, a component found to be critical [13, 14], is omitted from the majority of research studies on CI therapy [35].

To address transportation barriers, a telerehabilitation model of CI therapy delivery (AutoCITE) has been tested. AutoCITE is a large specialized motor apparatus (not commercially available, cost not established) that was installed in patients’ homes to enable therapeutic manipulation of actual objects with continuous video monitoring via Internet. This telerehabilitation approach demonstrated efficacy approximately equivalent to that of in-clinic CI therapy [36, 37, 38], thus establishing the feasibility of utilizing technology to deliver CI therapy remotely. However, this system involved specialized equipment at a high cost and did not become available outside a research setting.

To more fully address the barriers to accessing CI therapy and to counter the misconceptions surrounding CI therapy, a patient-centered treatment approach was developed that incorporated the high-repetition practice and carry-over strategies from CI therapy, while reforming non-patient-centric elements of the protocol that lack strong empirical support (i.e., the restraint). To deliver engaging high-repetition practice, a Kinect-based video game was created that can accommodate a wide range of motor disability, can be customized to each user, and automatically progresses in difficulty as the individual’s performance improves (termed “shaping” in the CI therapy literature). A player’s body movements drive game play (there is no external controller), which makes the game easy to use for those who may be unfamiliar with technology. To date, such high-repetition practice through motor gaming [39] has shown initial promise compared to traditional clinic-based approaches [40]. To promote increased use of the weaker arm, a smart watch biofeedback application is utilized in lieu of the restraint mitt. This application counts movements made with the weaker arm and provides alerts when a period of inactivity is detected. Previous approaches for providing CI therapy in the home and reducing the amount of therapist effort have been carried out [36, 37, 38, 41]. These approaches automated the delivery of training and permitted remote supervision of the training via an Internet-based audio-visual link, but did not embed the training within the context of a video game, rely on manipulation of virtual objects, or incorporate a patient-centric substitute for the mitt.

Initial evidence from a pilot trial of this system (Borstad A, Crawfis R, Phillips K, Pax Lowes L, Worthen-Chaudhari L, Maung D, et al.: In-home delivery of constraint induced movement therapy via virtual reality gaming is safe and feasible: a pilot study, submitted) suggests that improvements in motor speed, as measured by Wolf Motor Function Test (WMFT) performance time [42], an outcome of prime importance to stroke survivors, are approximately equivalent to those reported in the traditional CI therapy literature [5, 13, 19, 25]. Qualitative data reveal that the technology is accepted irrespective of age, technological expertise, ethnicity, or cultural background. Thus, this technology has the potential to address the main barriers to adoption of CI therapy, while reducing the cost of care. A randomized clinical trial is now required to provide Level 1 evidence of the comparative effectiveness of this novel model of CI therapy delivery. Data from this trial will enable individuals with motor disability to evaluate whether a home-based video game therapy has the potential to help them meet their rehabilitation goals compared to in-clinic CI therapy and traditional approaches. By combining novel gaming elements with the transfer package from CI therapy, this trial will also address a major limitation of rehabilitation gaming interventions that have been tried to date: extremely limited emphasis on carry-over of training to daily activities.

The primary objective of this trial is to compare the effectiveness of two video game-based models of CI therapy versus traditional clinic-based CI therapy versus standard upper extremity rehabilitation for improving upper extremity motor function. One video gaming group will match the number of total hours spent on the CI therapy transfer package, but will involve fewer days of therapist-client interaction (4 versus 10); the other will match the number of interactions with a therapist to that of clinic-based CI therapy using video consultation between in-person sessions and, as such, will involve more therapist contact hours spent focusing on the transfer package. The secondary objective of this project is to promote personalized medicine by examining individual factors that may differentially influence response to one treatment versus another.

Continue —>  Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis | BMC Neurology | Full Text

Fig. 1 Screen capture of the Recovery Rapids gaming environment

, , , , , , , , , , ,

Leave a comment

[Abstract] Effect of motor imagery on walking function and balance in patients after stroke: A quantitative synthesis of randomized controlled trials

 

Highlights

  • Motor imagery (MI) is a beneficial intervention for stroke rehabilitation.
  • MI shows superior to routine methods of treatment or training in improving walking and motor function.
  • Effects of MI on walking and motor function are not affected by treatment duration.

Abstract

Objective

This study aimed to evaluate effects of motor imagery (MI) on walking function and balance in patients after stroke.

Methods

Related randomized controlled trials (RCTs) were searched in 12 electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Science Direct, Web of Science, Allied and Complementary Medicine, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, WanFang, and VIP) from inception to November 30, 2016, and Review Manager 5.3 was used for meta-analysis. References listed in included papers and other related systematic reviews on MI were also screened for further consideration.

Results

A total of 17 studies were included. When compared with “routine methods of treatment or training,” meta-analyses showed that MI was more effective in improving walking abilities (standardized mean difference [SMD] = 0.69, random effect model, 95% confidence interval [CI] = 0.38 to 1.00, P < 0.0001) and motor function in stroke patients (SMD = 0.84, random effect model, 95% CI = 0.45 to 1.22, P < 0.0001), but no statistical difference was noted in balance (SMD = 0.78, random effect model, 95% CI = −0.07 to 1.62, P = 0.07). Statistically significant improvement in walking abilities was noted between short-term (0 to < six weeks) (SMD = 0.83, fixed effect model, 95% CI = 0.24 to 1.42, P = 0.006) and long-term (≥six weeks) durations (SMD = 0.45, fixed effect model, 95% CI = 0.25 to 0.64, P < 0.00001). Subgroup analyses results suggested that MI had a positive effect on balance with short-term duration (0 to < six weeks) (SMD = 4.67, fixed effect model, 95% CI = 2.89 to 6.46, P < 0.00001), but failed to improve balance (SMD = 0.82, random effect model, 95% CI = −0.27 to 1.90, P = 0.14) with long-term (≥six weeks) duration.

Conclusion

MI appears to be a beneficial intervention for stroke rehabilitation. Nonetheless, existing evidence regarding effectiveness of MI in stroke patients remains inconclusive because of significantly statistical heterogeneity and methodological flaws identified in the included studies. More large-scale and rigorously designed RCTs in future research with sufficient follow-up periods are needed to provide more reliable evidence on the effect of MI on stroke patients.

Source: Effect of motor imagery on walking function and balance in patients after stroke: A quantitative synthesis of randomized controlled trials – Complementary Therapies in Clinical Practice

, , , , , , , ,

Leave a comment

%d bloggers like this: