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StrokeNCT03261713

Home-based Virtual Reality Training After Stroke

A study testing Virtual reality in people with Stroke, run by Bruyère Health Research Institute. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Virtual reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
16 Aug 2017to 28 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Elisabeth Bruyère Hospital

    Ottawa, Ontario, K1N 5C8

Other trials in Canada

About this study

Official title: Home-based Virtual Reality Training After Discharge From Hospital-based Stroke Rehabilitation: A Parallel Randomised Feasibility Trial.

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).

Read the 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.

Conditions
Stroke
Being tested
Virtual reality, Control
Keywords
rehabilitation, telerehabilitation, feasibility studies, virtual reality
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual realityDevice

    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.

  • ControlDevice

    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.

Study groups in NCT03261713
Study groupRoleWhat they receive
Virtual RealityExperimentalVirtual reality training designed to train standing balance, reaching, stepping, gentle strengthening and aerobic conditioning.
Receives: Device: Virtual reality
ControlActive comparatoriPad apps designed to train memory, cognition, visual tracking and fine motor skills.
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    number of participants recruited over 18 months of participant intake relative to the number who met study criteria and number who were approached

    Measured: 18 months

  2. Quantitative assessment of ability and compliance to research protocol

    assessed by monitoring the use and progression of the VRT program

    Measured: 18 months

  3. Qualitative assessment of ability and compliance to research protocol

    assessed through comments made by the participant and study partner

    Measured: 18 months

  4. Adverse events (incidence & type) due to home-based VRT intervention

    presence of adverse effects (minor and severe) recorded from telephone conversations and through log book

    Measured: 18 months

  5. Ability to use VRT in the home

    assessed through comments made by the participant and study partner

    Measured: 18 months

  6. Quantitative assessment of acceptability of VRT intervention

    assessed with the Physical Activity Enjoyment Scale

    Measured: 18 months

  7. Qualitative assessment of acceptability of VRT intervention

    assessed through comments made by the participant and study partner

    Measured: 18 months

  8. Estimate cost for a future definitive RCT

    calculate costs of all components of this study

    Measured: 18 months

Secondary outcomes (18)
  1. Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration

    1. Berg Balance Scale (BBS, Berg et al.)

    Measured: 18 months

  2. Ability of participants to perform Timed Up & Go (original version) without quitting due to fatigue or frustration

    Timed Up And Go (TUG, original version, Campbell et al.)

    Measured: 18 months

  3. Ability of participants to perform Timed Up & Go (manual version) without quitting due to fatigue or frustration

    Timed Up And Go (TUG, manual version, Hofheinz \& Schusterschitz)

    Measured: 18 months

  4. Ability of participants to perform Timed Up & Go (cognitive version) without quitting due to fatigue or frustration

    Timed Up And Go (TUG, cognitive version, Lundin-Olsson et al.)

    Measured: 18 months

  5. Ability of participants to perform Five Times Sit-to-Stand without quitting due to fatigue or frustration

    Five Times Sit-to-Stand Test (FTSST, Bohannon et al.)

    Measured: 18 months

  6. Ability of participants to perform Community Balance & Mobility Scale without quitting due to fatigue or frustration

    Community Balance \& Mobility Scale (CBM, Howe et al.)

    Measured: 18 months

  7. Ability of participants to perform quantitative analysis of quiet stance in standing without quitting due to fatigue or frustration

    movement of the centre of pressure on a force plate during quiet stance in standing (Preuss \& Popovic)

    Measured: 18 months

  8. Ability of participants to perform quantitative analysis of limits of stability in standing without quitting due to fatigue or frustration

    quantitative assessment of the limits of stability in standing done on a force plate (Preuss \& Popovic)

    Measured: 18 months

  9. Potential for home-based VRT to maintain or improve performance on the Berg Balance Scale

    Berg Balance Scale (BBS, Berg et al.)

    Measured: 18 months

  10. Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (original version)

    Timed Up And Go (original version, Campbell et al.)

    Measured: 18 months

  11. Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (manual version)

    Timed Up And Go (manual version, Hofheinz \& Schusterschitz)

    Measured: 18 months

  12. Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (cognitive version)

    Timed Up And Go (cognitive version, Lundin-Olsson et al.)

    Measured: 18 months

  13. Potential for home-based VRT to maintain or improve performance on the Five Times Sit-To-Stand Test

    Five Times Sit-To-Stand Test (FTSST, Bohannon et al.)

    Measured: 18 months

  14. Potential for home-based VRT to maintain or improve performance on the Community Balance and Mobility Scale

    Community Balance and Mobility Scale (CBM, Howe et al.)

    Measured: 18 months

  15. Potential for home-based VRT to maintain or improve performance on quantitative analyses of quiet stance and limits of stability in standing

    quantitative analyses of quiet stance and limits of stability in standing (Preuss \& Popovic)

    Measured: 18 months

  16. Potential for home-based VRT to maintain or improve performance on the Stroke Impact Scale

    Stroke Impact Scale (SIS, Duncan et al.)

    Measured: 18 months

  17. Potential for home-based VRT to maintain or improve performance on the Reintegration to Normal Living Index

    Reintegration to Normal Living Index (RNLI, Spitzer et al).

    Measured: 18 months

  18. Determine a sample size for a definitive RCT on home-based VRT

    Results of the Berg Balance Scale (BBS, Berg et al.) to calculate sample size.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start16 Aug 2017
  3. Primary completion28 Nov 2018
  4. Study completion28 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261713
Sponsor's protocol ID
BAMO IF2017
Status last verified
Jul 2019
First submitted
13 Jun 2017
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Yang C, Welch V, Finestone H. Home-Based Nonimmersive Virtual Reality Training After Discharge From Inpatient or Outpatient Stroke Rehabilitation: Parallel Feasibility Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2025 Mar 28;12:e64729. doi: 10.2196/64729.

    PubMed 40153779
  • 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.

    PubMed 31174579

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Stroke, run by Bruyère Health Research Institute. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03261713, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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