- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261713
Home-based Virtual Reality Training After Stroke
Home-based Virtual Reality Training After Discharge From Hospital-based Stroke Rehabilitation: A Parallel Randomised Feasibility Trial.
Study Overview
Detailed Description
Stroke causes approximately 15 300 hospital admissions per year in Ontario and 50% of individuals who have had a stroke are left with moderate to severe impairment. Because of the severity of their condition, these individuals often cannot stand and have poor sitting and standing balance. Most patients who are discharged from inpatient stroke rehabilitation are 8-10 weeks post-stroke and have not completely recovered. Their brains are still in a period of enhanced neuroplasticity, during which great functional change can be made; Therapy outcomes are dose-dependent; intensive, high-repetition, task-oriented and task-specific therapies are most effective. Therefore, for the greatest recovery possible, these patients require ongoing therapy. Most are offered this on an outpatient basis. However, for many reasons (transportation difficulties, distance from downtown, weather etc.), not all eligible patients are able to attend outpatient therapy. Also, there is a waiting list and a limited number of outpatient therapy sessions are offered to each patient.
Virtual reality training (VRT) uses computer software to track the user's movements and allow him or her to interact with a game or activity presented on a TV screen. It is convenient, timely, and enjoyable, and may be done for an unlimited period post-stroke. VRT has been shown to benefit upper extremity function, standing balance, gait and overall function. Home-based VRT offers a promising addition or alternative to existing rehabilitation programs and home exercise programs that could make a significant difference in the lives of stroke survivors. A few pilot studies have investigated the use of home-based VRT for standing balance and upper extremity recovery after stroke and shown the feasibility of these systems for ongoing rehabilitation in the home. The investigators wish to expand on these studies by using a new VR system, made by Jintronix Inc. (Montreal, QC). This system was initially developed for stroke rehabilitation and has also been used extensively with healthy and frail elderly individuals. The Jintronix system is marketed for institutional and home use and has a simple-to-use interface but its home use has not yet been fully evaluated. The games are designed to incorporate motor learning principles such as multiple forms of feedback and task-specific practice that can be progressed to maintain an appropriate level of challenge. The purpose of this study is to investigate the feasibility, acceptance and safety of this new, simple-to-use VRT system used in the home, combined with substantial remote support for the user.
The primary objectives assessed the feasibility of using VRT in the home by patients post-stroke, using quantitative and qualitative methods. Specific objectives were:
- To estimate the recruitment rate of participants into the study;
- To assess the ability and compliance of the participants with respect to the components of the research protocol (ability to learn VRT through the training program; ability to comply with the exercise protocol; participant retention);
- To determine the safety of home-based VRT (presence of minor and major adverse events);
- To assess the ability of stroke survivors and their study partners to use VRT technology in the home (i.e. technical difficulties, difficulty learning the games);
- To assess the acceptability of the VRT intervention (enjoyment; perceived efficacy)
- To estimate the cost for a future definitive randomised control trial (RCT) on in-home VRT.
The secondary objectives assessed the feasibility of the outcome measures, using quantitative and qualitative methods. Specific objectives were:
- To assess the feasibility and acceptance of a battery of outcome measures, including physical assessments, questionnaires, an interview and a log book;
- To assess the potential that home-based VRT might maintain or improve physical outcomes (standing balance, gait, general function) and community integration after discharge from hospital-based stroke rehabilitation, compared to those who only participate in their regular activities of daily living.
- To determine the sample size required for a future definitive RCT on in-home VRT.
Procedures Participants in both the experimental and control groups (and their caregivers for those in the experimental group only) attend a total of 4 sessions at Élisabeth Bruyère Hospital. The first three sessions occur in the week or two before discharge from inpatient or outpatient rehabilitation. At sessions 1 and 2, each lasting approximately 60 minutes, participants and their study partners in the experimental group are trained on how to use the VRT system and play the games. They are also instructed what to do if something went wrong (for example, if the participant falls or the equipment does not work). Participants are given a simple manual on VRT. Participants in the control group also attend two training sessions, each lasting approximately 45 minutes, on how to use the tablet and use the apps. Outcome measures are performed at sessions 3 (before discharge) and 4 (after 6 weeks of VRT); each session takes approximately 1½ hours.
After discharge from inpatient or outpatient rehabilitation, the research physical therapist (PT) installs the VRT system into the participant's home and reviews the games, safety considerations and follow-up procedures with the participant and their study partner. The supervising caregiver must be in the home of the participant while he or she is doing VRT. The PT monitors the game and parameter selections along with time spent on VRT at least once a week using the remote access feature of the VRT system, and modifies the games if necessary.
Participants in both groups are instructed to perform their exercise plan 5 times a week for 6 weeks for 30 minutes at each session. This amount of additional training (15 hours) has been shown to produce a significant improvement in activities of daily living post-stroke. All participants are contacted by telephone twice a week for the first week and at least once a week for the following 5 weeks to offer encouragement, suggest modifications to the games and identify any safety issues or technical problems. Participants are also invited to contact the research PT as needed. Participants in both groups are encouraged to do as many activities of daily living (ADLs) and instrumental ADLs (IADLs) as they wish, including walking, participation in exercise groups and therapy. They are not prevented from undergoing further rehabilitation while enrolled in the feasibility study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1N 5C8
- Elisabeth Bruyère Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have had a stroke (ischemic or hemorrhagic) resulting in physical impairment;
- have enough preserved cognitive ability to learn VRT
- are receiving inpatient or outpatient stroke rehabilitation services;
- are able to stand independently for at least 2 minutes
- have a study partner who could attend 2 training sessions with the participant and was able to be in the home with the participant while doing VRT;
- can read, speak and understand English;
- live within 50 km of Élisabeth Bruyère Hospital;
- are able and willing to attend 4 appointments at Élisabeth Bruyère Hospital (2 for assessment; 2 for training);
- will not be travelling away from home for more than 2 days a week for the duration of the study;
- have enough space in their home to do VRT safely.
Exclusion Criteria:
- have an unstable medical condition, seizures or vertigo,
- are unable to perform mild to moderate exercise safely.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Virtual Reality
Virtual reality training designed to train standing balance, reaching, stepping, gentle strengthening and aerobic conditioning.
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Virtual reality training is provided using Jintronix Rehabilitation software.
A Kinect camera captures the movements of the participant using infrared technology and allows them to control an avatar, which interacts with an activity.
Several games and activities are available to train standing balance (ex.
slalom skiing), reaching (ex.
planting seeds/harvesting tomatoes), stepping (ex.
whack-a-mole), gentle strengthening (ex.
knee extensions) and aerobic exercises (ex.
marching on the spot).
Game and activity difficulty can be increased by requiring more repetitions, or greater speed, distance and/or accuracy.
Specific games and activities, and their parameters are customized for each participant.
The exercise plan is performed 5 times a week for 6 weeks for 30 minutes at each session.
|
ACTIVE_COMPARATOR: Control
iPad apps designed to train memory, cognition, visual tracking and fine motor skills.
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Participants in the control group are provided with an iPad which contains a selection of apps suited for memory (ex.
memory card game), cognition (Sudoku, cross-word), visual tracking (word search) and fine motor skills (ex.
writing, whack-a-mole).
Participants are instructed to perform their exercise plan 5 times a week for 6 weeks for 30 minutes at each session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: 18 months
|
number of participants recruited over 18 months of participant intake relative to the number who met study criteria and number who were approached
|
18 months
|
Quantitative assessment of ability and compliance to research protocol
Time Frame: 18 months
|
assessed by monitoring the use and progression of the VRT program
|
18 months
|
Qualitative assessment of ability and compliance to research protocol
Time Frame: 18 months
|
assessed through comments made by the participant and study partner
|
18 months
|
Adverse events (incidence & type) due to home-based VRT intervention
Time Frame: 18 months
|
presence of adverse effects (minor and severe) recorded from telephone conversations and through log book
|
18 months
|
Ability to use VRT in the home
Time Frame: 18 months
|
assessed through comments made by the participant and study partner
|
18 months
|
Quantitative assessment of acceptability of VRT intervention
Time Frame: 18 months
|
assessed with the Physical Activity Enjoyment Scale
|
18 months
|
Qualitative assessment of acceptability of VRT intervention
Time Frame: 18 months
|
assessed through comments made by the participant and study partner
|
18 months
|
Estimate cost for a future definitive RCT
Time Frame: 18 months
|
calculate costs of all components of this study
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration
Time Frame: 18 months
|
1) Berg Balance Scale (BBS, Berg et al.)
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18 months
|
Ability of participants to perform Timed Up & Go (original version) without quitting due to fatigue or frustration
Time Frame: 18 months
|
Timed Up And Go (TUG, original version, Campbell et al.)
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18 months
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Ability of participants to perform Timed Up & Go (manual version) without quitting due to fatigue or frustration
Time Frame: 18 months
|
Timed Up And Go (TUG, manual version, Hofheinz & Schusterschitz)
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18 months
|
Ability of participants to perform Timed Up & Go (cognitive version) without quitting due to fatigue or frustration
Time Frame: 18 months
|
Timed Up And Go (TUG, cognitive version, Lundin-Olsson et al.)
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18 months
|
Ability of participants to perform Five Times Sit-to-Stand without quitting due to fatigue or frustration
Time Frame: 18 months
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Five Times Sit-to-Stand Test (FTSST, Bohannon et al.)
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18 months
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Ability of participants to perform Community Balance & Mobility Scale without quitting due to fatigue or frustration
Time Frame: 18 months
|
Community Balance & Mobility Scale (CBM, Howe et al.)
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18 months
|
Ability of participants to perform quantitative analysis of quiet stance in standing without quitting due to fatigue or frustration
Time Frame: 18 months
|
movement of the centre of pressure on a force plate during quiet stance in standing (Preuss & Popovic)
|
18 months
|
Ability of participants to perform quantitative analysis of limits of stability in standing without quitting due to fatigue or frustration
Time Frame: 18 months
|
quantitative assessment of the limits of stability in standing done on a force plate (Preuss & Popovic)
|
18 months
|
Potential for home-based VRT to maintain or improve performance on the Berg Balance Scale
Time Frame: 18 months
|
Berg Balance Scale (BBS, Berg et al.)
|
18 months
|
Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (original version)
Time Frame: 18 months
|
Timed Up And Go (original version, Campbell et al.)
|
18 months
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Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (manual version)
Time Frame: 18 months
|
Timed Up And Go (manual version, Hofheinz & Schusterschitz)
|
18 months
|
Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (cognitive version)
Time Frame: 18 months
|
Timed Up And Go (cognitive version, Lundin-Olsson et al.)
|
18 months
|
Potential for home-based VRT to maintain or improve performance on the Five Times Sit-To-Stand Test
Time Frame: 18 months
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Five Times Sit-To-Stand Test (FTSST, Bohannon et al.)
|
18 months
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Potential for home-based VRT to maintain or improve performance on the Community Balance and Mobility Scale
Time Frame: 18 months
|
Community Balance and Mobility Scale (CBM, Howe et al.)
|
18 months
|
Potential for home-based VRT to maintain or improve performance on quantitative analyses of quiet stance and limits of stability in standing
Time Frame: 18 months
|
quantitative analyses of quiet stance and limits of stability in standing (Preuss & Popovic)
|
18 months
|
Potential for home-based VRT to maintain or improve performance on the Stroke Impact Scale
Time Frame: 18 months
|
Stroke Impact Scale (SIS, Duncan et al.)
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18 months
|
Potential for home-based VRT to maintain or improve performance on the Reintegration to Normal Living Index
Time Frame: 18 months
|
Reintegration to Normal Living Index (RNLI, Spitzer et al).
|
18 months
|
Determine a sample size for a definitive RCT on home-based VRT
Time Frame: 18 months
|
Results of the Berg Balance Scale (BBS, Berg et al.) to calculate sample size.
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hillel Finestone, MD, Bruyere Continuing Care
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAMO IF2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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