Clinical trial NCT03261713: Home-based Virtual Reality Training After Stroke
Official title: Home-based Virtual Reality Training After Discharge From Hospital-based Stroke Rehabilitation: A Parallel Randomised Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
telerehabilitation
feasibility studies
virtual reality
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: Bruyere Academic Medical Organization
First posted: 2017-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, single-site, single-blinded, parallel-group (1:1 ratio) randomized feasibility trial on the use of VRT for ongoing stroke rehabilitation after discharge from inpatient or outpatient stroke rehabilitation.
Primary purpose: TREATMENT

Brief summary: Virtual reality (VR) training (VRT) uses computer software to track a user's movements and allow them to interact with a game presented on a TV. It is fun and engaging and may encourage the user to do more exercise. VRT is increasingly being used for rehabilitation after stroke. Patients often require ongoing therapy post-discharge from inpatient rehabilitation. Outpatient therapy may be unavailable due to waiting lists, transportation issues, distance etc.; therefore, home-based VRT may be the answer. Our objectives are to determine: 1) the feasibility of home-based VRT for stroke patients after discharge from hospital-based rehabilitation, and 2) the feasibility of a battery of outcome measures. Forty stroke rehabilitation patients will be recruited over 18 months and randomize them to experimental or control groups. VRT participants will be introduced to VRT at the hospital and a VRT system will be set up in their homes shortly after discharge. Control participants will be provided with games and apps on an iPad focusing on cognition and fine motor skills. Participants will be instructed to perform 30 minutes of VRT 5 days a week for 6 weeks. Training will be monitored remotely. Both groups will receive weekly phone calls to review their home activity and answer questions. Measurements will be made of standing balance and general function before and after training, and feasibility (compliance, enjoyment, safety).

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:

1. To estimate the recruitment rate of participants into the study;
2. 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);
3. To determine the safety of home-based VRT (presence of minor and major adverse events);
4. 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);
5. To assess the acceptability of the VRT intervention (enjoyment; perceived efficacy)
6. 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:

1. To assess the feasibility and acceptance of a battery of outcome measures, including physical assessments, questionnaires, an interview and a log book;
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. have had a stroke (ischemic or hemorrhagic) resulting in physical impairment;
2. have enough preserved cognitive ability to learn VRT
3. are receiving inpatient or outpatient stroke rehabilitation services;
4. are able to stand independently for at least 2 minutes
5. 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;
6. can read, speak and understand English;
7. live within 50 km of Élisabeth Bruyère Hospital;
8. are able and willing to attend 4 appointments at Élisabeth Bruyère Hospital (2 for assessment; 2 for training);
9. will not be travelling away from home for more than 2 days a week for the duration of the study;
10. have enough space in their home to do VRT safely.

Exclusion Criteria:

1. have an unstable medical condition, seizures or vertigo,
2. are unable to perform mild to moderate exercise safely.

Primary outcomes:
measure: Recruitment rate
timeFrame: 18 months
measure: Quantitative assessment of ability and compliance to research protocol
timeFrame: 18 months
measure: Qualitative assessment of ability and compliance to research protocol
timeFrame: 18 months
measure: Adverse events (incidence & type) due to home-based VRT intervention
timeFrame: 18 months
measure: Ability to use VRT in the home
timeFrame: 18 months
measure: Quantitative assessment of acceptability of VRT intervention
timeFrame: 18 months
measure: Qualitative assessment of acceptability of VRT intervention
timeFrame: 18 months
measure: Estimate cost for a future definitive RCT
timeFrame: 18 months
Secondary outcomes:
measure: Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform Timed Up & Go (original version) without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform Timed Up & Go (manual version) without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform Timed Up & Go (cognitive version) without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform Five Times Sit-to-Stand without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform Community Balance & Mobility Scale without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform quantitative analysis of quiet stance in standing without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Ability of participants to perform quantitative analysis of limits of stability in standing without quitting due to fatigue or frustration
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Berg Balance Scale
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (original version)
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (manual version)
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (cognitive version)
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Five Times Sit-To-Stand Test
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Community Balance and Mobility Scale
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on quantitative analyses of quiet stance and limits of stability in standing
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Stroke Impact Scale
timeFrame: 18 months
measure: Potential for home-based VRT to maintain or improve performance on the Reintegration to Normal Living Index
timeFrame: 18 months
measure: Determine a sample size for a definitive RCT on home-based VRT
timeFrame: 18 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Elisabeth Bruyère Hospital
state: Ontario
Study officials:
affiliation: Bruyere Continuing Care
name: Hillel Finestone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Yang C, Welch V, Hossain A, Finestone H. Home-based virtual reality training after discharge from hospital-based stroke rehabilitation: a parallel randomized feasibility trial. Trials. 2019 Jun 7;20(1):333. doi: 10.1186/s13063-019-3438-9.