Posts Tagged Randomized controlled trial

[Abstract] A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia

Abstract

Objective

Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only).

Methods

Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units.

Participants

Stroke survivors with homonymous hemianopia.

Interventions

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).

Inclusion criteria

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.

Outcomes

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

Randomization block lists stratified by site and partial/complete hemianopia.

Blinding

Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation.

Results

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).

Conclusions

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

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[ARTICLE] Home-based hand rehabilitation after chronic stroke: Randomized, controlled single-blind trial comparing the MusicGlove with a conventional exercise program

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.

 

INTRODUCTION

Hand impairment after stroke contributes substantially to disability in the United States and around the world [1]. 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 [14]; 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 [15]. Another common approach is telerehabilitation, which allows a therapist to guide therapy remotely [16]. 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 [17]. Other approaches to home-based hand rehabilitation include functional electrical stimulation [18], computer gaming with custom devices [19–21], and music-based therapy [22]. However, despite the variety of options, few home-based programs have been tested in controlled studies [23]. 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.

Figure 1. MusicGlove device used in study. Users are visually cued by scrolling notes on screen (top) to make specific grips in time with popular songs, similar to the video game Guitar Hero. Grips include (a) key pinch grip; (b) pincer grip; and (c) finger-thumb opposition with second, third, and fourth fingers. During gameplay, the user must complete the cued grip when a colored note passes over the starred strip shown at bottom of the game screen (time window of about 800 ms). If the user is successful, the colored note disappears, providing visual feedback. If the user is unsuccessful, a beep is played, providing auditory feedback.

Figure 1. MusicGlove device used in study. Users are visually cued by scrolling notes on screen (top) to make specific grips in time with popular songs, similar to the video game Guitar Hero. Grips include (a) key pinch grip; (b) pincer grip; and (c) finger-thumb opposition with second, third, and fourth fingers. During gameplay, the user must complete the cued grip when a colored note passes over the starred strip shown at bottom of the game screen (time window of about 800 ms). If the user is successful, the colored note disappears, providing visual feedback. If the user is unsuccessful, a beep is played, providing auditory feedback.

Continue —> Home-based hand rehabilitation after chronic stroke: Randomized, controlled single-blind trial comparing the MusicGlove with a conventional exercise program

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[Abstract] Effectiveness and safety of Chinese massage therapy (Tui Na) on post-stroke spasticity: A prospective multicenter randomized controlled trial

Abstract

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.

Source: Effectiveness and safety of Chinese massage therapy (Tui Na) on post-stroke spasticity: A prospective multicenter randomized controlled trial

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[Abstract] Does the method of botulinum neurotoxin injection for limb spasticity affect outcomes? A systematic review.

Abstract

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.

Source: Does the method of botulinum neurotoxin injection for limb spasticity affect outcomes? A systematic review

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[Abstract] Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: A randomized controlled trial and economics analysis

Abstract

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.

Source: Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: A randomized controlled trial and economics analysis

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[Abstract] A Telehealth Approach to Caregiver Self-Management Following Traumatic Brain Injury: A Randomized Controlled Trial

Abstract

Objective: To determine whether a telephone-based, individualized education and mentored problem-solving intervention would improve outcomes for caregivers of persons with traumatic brain injury (TBI).

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.

Source: A Telehealth Approach to Caregiver Self-Management Following… : The Journal of Head Trauma Rehabilitation

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[ARTICLE] Design of a Smartphone Application with Integrated Functional Electrical Stimulation (FES) Treatment Randomization and On-The-Fly Stimulus Parameter Adjustment for Streamlining the Clinical Evaluation of FES Protocols – Full Text PDF

Abstract

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.

Download Full Text PDF

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[Abstract] Does the use of Nintendo Wii Sports improve arm function? Trial of Wii in Stroke: A randomized controlled trial and economics analysis

Abstract

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.

Source: Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: A randomized controlled trial and economics analysis

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[Abstract] Effects of Unilateral Upper Limb Training in Two Distinct Prognostic Groups Early After Stroke

Abstract

Background and Objective. Favorable prognosis of the upper limb depends on preservation or return of voluntary finger extension (FE) early after stroke. The present study aimed to determine the effects of modified constraint-induced movement therapy (mCIMT) and electromyography-triggered neuromuscular stimulation (EMG-NMS) on upper limb capacity early poststroke.

Methods. A total of 159 ischemic stroke patients were included: 58 patients with a favorable prognosis (>10° of FE) were randomly allocated to 3 weeks of mCIMT or usual care only; 101 patients with an unfavorable prognosis were allocated to 3-week EMG-NMS or usual care only. Both interventions started within 14 days poststroke, lasted up until 5 weeks, focused at preservation or return of FE.

Results. Upper limb capacity was measured with the Action Research Arm Test (ARAT), assessed weekly within the first 5 weeks poststroke and at postassessments at 8, 12, and 26 weeks. Clinically relevant differences in ARAT in favor of mCIMT were found after 5, 8, and 12 weeks poststroke (respectively, 6, 7, and 7 points; P < .05), but not after 26 weeks. We did not find statistically significant differences between mCIMT and usual care on impairment measures, such as the Fugl-Meyer assessment of the arm (FMA-UE). EMG-NMS did not result in significant differences.

Conclusions. Three weeks of early mCIMT is superior to usual care in terms of regaining upper limb capacity in patients with a favorable prognosis; 3 weeks of EMG-NMS in patients with an unfavorable prognosis is not beneficial. Despite meaningful improvements in upper limb capacity, no evidence was found that the time-dependent neurological improvements early poststroke are significantly influenced by either mCIMT or EMG-NMS.

Source: Effects of Unilateral Upper Limb Training in Two Distinct Prognostic Groups Early After Stroke

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[ARTICLE] The effects of mirror therapy on the gait of subacute stroke patients: a randomized controlled trial

Abstract

Objective: To investigate the effect of mirror therapy on the gait of patients with subacute stroke.

Design: Randomized controlled experimental study.

Setting: Outpatient rehabilitation hospital.

Subjects: Thirty-four patients with stroke were randomly assigned to two groups: a mirror therapy group (experimental) and a control group.

Interventions: The stroke patients in the experimental group underwent comprehensive rehabilitation therapy and mirror therapy for the lower limbs. The stroke patients in the control group underwent sham therapy and comprehensive rehabilitation therapy. Participants in both groups received therapy five days per week for four weeks.

Main measures: Temporospatial gait characteristics, such as single stance, stance phase, step length, stride, swing phase, velocity, and cadence, were assessed before and after the four weeks therapy period.

Results: A significant difference was observed in post-training gains for the single stance (10.32 SD 4.14 vs. 6.54 SD 3.23), step length (8.47 SD 4.12 vs. 4.83 SD 2.14), and stride length (17.03 SD 6.57 vs 10.54 SD 4.34) between the experimental group and the control group (p 0.05).

Conclusion: We conclude that mirror therapy may be beneficial in improving the effects of stroke on gait ability.

via The effects of mirror therapy on the gait of subacute stroke patients: a randomized controlled trial.

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