Results Summary
PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.
Background
After a stroke, some people have a hard time using their arms or hands. This can make it hard for them to do everyday activities and enjoy life. A type of movement therapy can help people who have had a stroke to use their arms and hands more easily. However, many patients can’t get the therapy because they don’t live near a place that offers it.
Project Purpose
This study had three goals:
- To see if using a video game, with a little supervision from a therapist, helped people after a stroke
- To see how much the video game helped people recover use of their arms and hands
- To see if the game-based movement therapy worked differently depending on the other types of problems patients had after a stroke, like trouble thinking clearly or limited feeling in their hands
Methods
Sixteen people participated in the study. All participants had experienced weakness in one arm or hand for at least six months, but they could move their arms at least a little bit. The participants had never had this type of movement therapy before the study, and they hadn’t received Botox injections in the 12 weeks before the study. (Botox injections are sometimes used to reduce spasms in people who have had a stroke.) During the three-week study period, the participants didn’t get any other kind of therapy to treat their arm weakness. The participants had to be willing to wear a special glove to play the video game.
During the study, participants got the movement therapy at home by playing a video game. Participants played the video game on their own and talked with a therapist as needed.
Researchers gave participants three physical tests to measure how well they could use their arms and hands before they played the video game. They gave participants the tests again after they played the video game.
The researchers also looked at how helpful the movement therapy was for the participants who had other stroke-related problems, like such as trouble thinking clearly or limited feeling in their hands.
Findings
The study found that playing the video game helped participants to move their arms and hands more easily. The game also helped improve feeling in the arms and hands of some participants. The video game was safe to use at home without a therapist present, and participants liked the video game.
People who had memory and thinking problems from their stroke improved their arm and hand movements less than other participants.
Researchers learned that participants didn’t do all of the suggested tasks in the video game. Participants also didn’t like using the special glove that was part of the therapy because it was hard to put on and take off, and it got dirty. That meant that some patients in the study did not complete the full amount of movement therapy. As a result, participants in this study didn’t improve their arm and hand movement as much as people usually do when they get the therapy with a therapist.
Limitations
Only a few people participated in the study, and not all participants played the same version of the video game. The study results could be different with more participants.
Conclusions
This project provided information to help researchers plan studies using movement therapy at home and to determine whether movement therapy would be a good way to help people move their arms and hands more easily after having a stroke. Home-based therapy is especially important for patients who can’t easily get to therapy appointments. Additional work needs to be done to make the video game easier to use.
Professional Abstract
PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.
Project Purpose
Impairments in the hand and arm result in diminished quality of life for persons post-stroke. Constraint-induced movement therapy (CI therapy) substantially increases arm function, increases spontaneous use of the more affected arm, and promotes structural and functional brain plasticity. Despite some evidence of effectiveness, CI therapy remains inaccessible to most patients due to limited availability of treatment programs.
The purposes of this study were threefold: (1) to determine the safety and feasibility of delivering CI therapy with minimal direct therapist supervision using a custom, avatar-based virtual reality game to deliver high-repetition motor practice; (2) to document the extent of motor recovery for the purpose of planning larger controlled studies; and (3) to conduct a preliminary assessment of the relationship between participant characteristics and outcomes.
Study Design
Prospective cohort study with a pre-test/post-test quasi-experimental design
Participants, Interventions, Settings, and Outcomes
Sixteen community-dwelling individuals with upper extremity hemiparesis were included in the study. Participants met the following study criteria: (1) hemiparesis for ≥6 months; (2) capacity to provide informed consent; (3) not receiving concurrent outpatient rehabilitation for their upper extremity; (4) no history of having received CI therapy or modified CI therapy; (5) 30° active shoulder flexion, 20° active elbow extension, at least 10° active wrist extension, at least 10° thumb abduction/extension, and at least 10° extension in at least two digits; (6) the expressed willingness to wear the restraint mitt; and (7) not having received Botox injections within 12 weeks of study participation.
The intervention for this study was an in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log (MAL) with problem solving were delivered via a custom avatar-based video game called Recovery Rapids. Behavioral data before and after training were collected in an academic medical center research laboratory.
The Wolf Motor Function Test Rate Metric (WMFT) and Motor Activity Log Quality of Movement (MAL QOM) were chosen as the primary outcome measures for this study because they have excellent psychometric properties and they measure distinct aspects of motor ability that are important to the post-stroke community. The Action Research Arm Test (ARAT)—a 19-item measure of quality of movement during grasp, grip, pinch, and gross movement—served as an exploratory motor measure.
Data Analysis
Data were examined for normality using the Shapiro-Wilk test (p ≥0.05). Student’s paired t-tests were run separately for primary and exploratory outcome variables to estimate the treatment effect. For the primary outcome analysis, alpha was set at ≤0.025 after Bonferroni correction for two comparisons. Analysis of exploratory outcome measures was conducted without correction for multiple comparisons to identify trends in the data, defined as p≤0.1. Effect size was calculated for outcomes that were statistically different at posttest. A mixed-effects repeated measures ANOVA was used to determine whether those with impaired cognition, kinesthetic sense, or tactile perception experienced poorer outcomes.
There were no missing data for the primary outcomes; two percent of the data were missing overall. No systematic differences between missing and non-missing data were detected; thus, data were considered to be missing at random. Restricted maximum likelihood was chosen as the method to impute missing data because it is recommended when data are missing at random in relatively small data sets such as this.
Findings
This pilot study demonstrated that despite high-repetition of nonsupervised motor practice, the intervention was safe, feasible overall, well-received by participants, and showed preliminary evidence for increasing performance speed and quality of upper extremity use.
No adverse events were reported during this study, thus it met the a priori criteria for safety. Gaming CI therapy showed a large effect on the primary outcome measures of WMFT rate and MAL QOM. The average MAL QOM change of 0.7 on the five-point scale exceeded the proposed minimal clinically important difference of 10 percent of the total range.
A mixed-effects repeated measures ANOVA was used to determine whether those with impaired cognition (Montreal Cognitive Assessment<26/30), kinesthetic sense (Brief Kinesthesia Test >6.5 cm error), or tactile perception (Touch Test >4 g) experienced less change in WMFT rate or MAL QOM. There was a significant effect of cognition on MAL QOM change (F = 7.5, p = 0.02). No other relationships were identified.
Overall, compliance with in-game MAL problem solving and mitt use was poor. Qualitative feedback from participants suggested both that the game overshadowed the importance of the transfer package (including in-game MAL) and that the substantially reduced therapist contact time made participants feel less accountable for performing therapeutic tasks that are distasteful (mitt restraint) or less engaging (in-game MAL). The mitt was particularly disliked because it was time consuming to get on and off, impeded hygiene (e.g., washing hands), and got dirty. The result was that participants received a much lower “dose” of the transfer package, techniques known to be important for carry-over of motor gains to daily activities. Accordingly, improvement in quality of upper extremity arm use for daily activities was less than half as large as that observed with traditional CI therapy, although still clinically meaningful.
Limitations
This pilot study had a small sample size and no comparison group. As such, no definitive conclusions regarding efficacy can be drawn. The study was conducted concurrently with game design, so not all participants played the same version of Recovery Rapids.
Conclusions
Future directions of this work include establishing a stronger causative link between this intervention and clinical outcomes through a multisite randomized controlled trial, modifying the delivery of the transfer package using a patient-centered approach to enhance carryover, and performing a well-powered subgroup analysis to determine the influence of somatosensory and cognitive functioning on outcomes.
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Dissemination Activities
Through limited competition, PCORI awarded 25 of the 50 Pilot Projects up to $50,000 to support dissemination and implementation of their activities and findings through the PCORI Pilot Project Learning Network (PPPLN) funding. The deliverables listed below are a result of convenings and conferences supported by this funding, whose efforts align with the PCORI strategic goal of disseminating information and encouraging adoption of PCORI-funded research results.
Period: November 2015 to January 2016
Budget: $50,000
- Created a video series that describes the research behind CI therapy
- Created a more user-friendly version of Recovery Rapids, the software product featured in the educational videos that delivers CI therapy in home