Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only).
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®).
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.
Customized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.
Stroke, the most common cerebrovascular disease, is a focal neurological disorder of abrupt development due to a pathological process in blood vessels . 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 ; 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 .
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 [4, 5]. 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 . 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 . Generally, cognitive impairment derived from stroke includes alterations in attention, memory, and executive function .
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 [9, 10, 11, 12].
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 . 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 ® )  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 . Transfer of learning is included within the concept of generalization when specifically referring to the ability to apply specific strategies to related tasks . Two types of transfer have been proposed – near transfer and far transfer . 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 . 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 .[…]
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.
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).
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.
Clinical practice guidelines recommend outpatient rehabilitation for stroke survivors who remain disabled after discharge from inpatient rehabilitation . Although these guidelines recommend that the majority of stroke survivors receive at least some outpatient rehabilitation , many cannot access long-term care . 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  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 , 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 .
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 . 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 .
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 . 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 . 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 .
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  has shown initial promise compared to traditional clinic-based approaches . 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 , 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
Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only).
Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units.
Stroke survivors with homonymous hemianopia.
Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care—information only).
Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent.
Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks.
Randomization block lists stratified by site and partial/complete hemianopia.
Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation.
Eighty-seven patients were recruited: 27—Fresnel prisms, 30—visual search training and 30—standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree2 visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19.4] to 59.8 [SD 22.7]: 10% difference), P=.05. Related adverse events were common with Fresnel prisms (69.2%; typically headaches).
No significant change occurred for area of visual field area across arms over follow-up. Visual search training had significant improvement in vision-related quality of life. Prism therapy produced adverse events in 69%. Visual search training results warrant further investigation.
Source: A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia – Rowe – 2016 – Acta Neurologica Scandinavica – Wiley Online Library
Abstract — Individuals with chronic stroke have limited options for hand rehabilitation at home. Here, we sought to determine the feasibility and efficacy of home-based MusicGlove therapy. Seventeen participants with moderate hand impairment in the chronic phase of stroke were randomized to 3 wk of home-based exercise with either the MusicGlove or conventional tabletop exercises. The primary outcome measure was the change in the Box and Blocks test score from baseline to 1 mo post treatment. Both groups significantly improved their Box and Blocks test score, but no significant difference was found between groups. The MusicGlove group did exhibit significantly greater improvements than the conventional exercise group in Motor Activity Log Quality of Movement and Amount of Use scores 1 mo posttherapy (p = 0.007 and p = 0.04, respectively). Participants significantly increased their use of MusicGlove over time, completing 466 gripping movements per day on average at study end. MusicGlove therapy was not superior to conventional tabletop exercises for the primary end point but was nevertheless feasible and led to a significantly greater increase in self-reported functional use and quality of movement of the impaired hand than conventional home exercises.
Hand impairment after stroke contributes substantially to disability in the United States and around the world . Intensive movement practice can reduce hand impairment [2–6], but issues such as cost and access may limit the dose of rehabilitation exercise delivered one-on-one with a therapist. Because of these and other factors, most individuals do not perform the large number of exercise repetitions required during therapy to maximize recovery [7–8]. Home-based rehabilitation programs may be prescribed after stroke with the intent to increase the amount of rehabilitation exercise individuals perform. However, the most common approach to home-based hand therapy is following a printed handout of exercises. This approach is often not motivating and thus is associated with low compliance and high dropout rates [9–13].
To address this problem, other types of home-based rehabilitation programs for the hand have been proposed. For example, one pilot study explored a modified form of constraint-induced movement therapy performed under the supervision of a nonprofessional coach in the home and found similar benefits to the same program performed with a trained therapist in a clinic ; a larger study using this protocol found that home-based constraint-induced movement therapy led to significantly greater self-reported use of the impaired limb than conventional therapy . Another common approach is telerehabilitation, which allows a therapist to guide therapy remotely . While this approach is gaining popularity, a recent Cochrane systematic review of 10 trials with 933 total participants found limited evidence to support its use and no studies that examined its cost-effectiveness . Other approaches to home-based hand rehabilitation include functional electrical stimulation , computer gaming with custom devices [19–21], and music-based therapy . However, despite the variety of options, few home-based programs have been tested in controlled studies . Further, it is still unclear which methods are the most effective and efficient means of providing an increased dose of rehabilitation, though the use of computer games and music has been found to be highly motivating [20,24–26].
We developed the MusicGlove, an instrumented glove with sensors on each of the fingertips and the lateral aspect of the index finger. The MusicGlove requires the user to practice functional gripping movements by touching the sensor on the tip of the thumb to one of the other five sensors in time with music through a video game that displays scrolling notes on a screen (Figure 1). In previous pilot studies performed in a clinical setting, we found that the MusicGlove motivated individuals with chronic stroke to perform hundreds of functional gripping movements during a 30 min training session and that exercise with the device led to a significantly greater improvement in hand grasping ability, measured with the Box and Blocks test, than a time-matched dose of conventional tabletop therapy performed with a rehabilitation therapist [27–28]. The individuals who used the MusicGlove also reported that the exercise was more motivating than conventional therapy and expressed interest in using the device to exercise at home. An important question, therefore, was whether self-guided exercise with the MusicGlove performed at home is feasible and improves hand function compared with conventional home therapy.
Objective: To evaluate the effectiveness and safety of Chinese massage therapy (Tui Na) for patients with post-stroke spasticity.
Design: A prospective, multicenter, blinded, randomized, placebo-controlled intervention trial.
Subject: A total of 90 patients with post-stroke spasticity were randomly assigned to the experimental (Tui Na therapy) group (n = 45) or control (placebo Tui Na therapy) group (n = 45).
Intervention: Participants in the experimental group received Tui Na therapy, while those in the control group received placebo-Tai Na (gentle rubbing) for 20–25 minutes per limb, once per day, five days per week for a total of four weeks. All participants in both groups received conventional rehabilitation.
Main measure: The Modified Ashworth Scale, the Fugl-Meyer Assessment and the Modified Barthel Index were used to assess the severity of spasticity, motor function of limbs and activities of daily living, respectively. Assessments were performed at baseline, at four weeks and at three months.
Results: Tui Na group had a significantly greater reduction in Modified Ashworth Scale in only four muscle groups than the control did (elbow flexors, P = 0.026; wrist flexors, P = 0.005; knee flexors, P = 0.023; knee extensors, P = 0.017). Improvements were sustained at three months follow-up. There was no significant difference between the two groups in Fugl-Meyer Assessment (P = 0.503) and Modified Barthel Index (P = 0.544). No adverse reaction was recorded in any of the cases mentioned at all study sites.
Conclusions: Tui Na might be a safe and effective treatment to reduce post-stroke spasticity of several muscle groups.
Objective: To systematically review randomized controlled trials of botulinum neurotoxin for limb spasticity to determine whether different injection techniques affect spasticity outcomes.
Methods: MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human randomized controlled trials from 1990 to 13 May 2016. Studies were assessed in duplicate for data extraction and risk of bias using the Physiotherapy Evidence Database scale and graded according to Sackett’s levels of evidence.
Results: Nine of 347 studies screened met selection criteria. Four categories of botulinum neurotoxin injection techniques were identified: (1) injection localization technique; (2) injection site selection; (3) injectate volume; (4) injection volume and site selection. There is level 1 evidence that: ultrasound, electromyography, and electrostimulation are superior to manual needle placement; endplate injections improve outcomes vs. multisite quadrant injections; motor point injections are equivalent to multisite injections; high volume injections are similar to low volume injections; and high volume injections distant from the endplate are more efficacious than low volumes closer to the endplate.
Conclusion: Level 1 evidence exists for differences in treatment outcomes using specific botulinum neurotoxin injection techniques. Findings are based on single studies that require independent replication and further study.
Objective: The Trial of Wii™ in Stroke investigated the efficacy of using the Nintendo Wii Sports™ (WiiTM) to improve affected arm function after stroke.
Design: Multicentre, pragmatic, parallel group, randomized controlled trial.
Setting: Home-based rehabilitation.
Subjects: A total of 240 participants aged 24–90 years with arm weakness following a stroke within the previous six months.
Intervention: Participants were randomly assigned to exercise daily for six weeks using the WiiTM or arm exercises at home.
Main measures: Primary outcome was change in the affected arm function at six weeks follow-up using the Action Research Arm Test. Secondary outcomes included occupational performance, quality of life, arm function at six months and a cost effectiveness analysis.
Results: The study was completed by 209 participants (87.1%). There was no significant difference in the primary outcome of affected arm function at six weeks follow-up (mean difference −1.7, 95% CI −3.9 to 0.5, p = 0.12) and no significant difference in secondary outcomes, including occupational performance, quality of life or arm function at six months, between the two groups. No serious adverse events related to the study treatment were reported. The cost effectiveness analysis showed that the WiiTM was more expensive than arm exercises £1106 (SD 1656) vs. £730 (SD 829) (probability 0.866).
Conclusion: The trial showed that the WiiTM was not superior to arm exercises in home-based rehabilitation for stroke survivors with arm weakness. The WiiTM was well tolerated but more expensive than arm exercises.
Design: Parallel group, randomized controlled trial with blinded outcome assessment.
Setting: General community.
Participants: A total of 153 caregivers (mean age = 49.7 years; 82% female; 54% spouses/partners, 35% parents) of persons with moderate to severe TBI who received acute and/or rehabilitation care at a level I trauma center. Eighty-two percent of participants were evaluated at 6-month follow-up.
Intervention: Individualized education and mentored problem-solving intervention focused on caregivers’ primary concerns delivered via up to 10 telephone calls at 2-week intervals.
Main Outcome Measures: Composite of Bakas Caregiving Outcomes Scale (BCOS) and Brief Symptom Inventory (BSI-18) at 6 months post-TBI survivor discharge. Secondary measures included the Brief COPE.
Results: Caregivers in the treatment arm scored higher on the BCOS-BSI composite (P = .032), with more active coping (P = .020) and less emotional venting (P = .028) as measured by the Brief COPE.
Conclusions: An individualized education and mentored problem-solving approach delivered via telephone in the first few months following community discharge of the TBI survivor resulted in better caregiver outcomes than usual care. Consideration should be given to using this approach to augment the limited support typically offered to caregivers.
The clinical application of Functional Electrical Stimulation (FES) has evolved over the last five decades.
However, the use of the Randomized Control Trial (RCT) methodology in evaluating the clinical effectiveness of new and existing applications of FES is a demanding process adding time and cost to these trials.
Consequently, there has been a low level of RCTs applied to FES studies. Poor quality trials result in poor evidence of FES effectiveness with a consequence that the technique may not be adopted into clinical practice.
In this paper some of the key challenges encountered in FES randomised control clinical trials are identified and a solution to address these challenges is presented in the form of a smartphone App and a Bluetooth controlled FES architecture.
The design and evaluation of a smartphone application using a User Centred Design approach to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled FES device is described.