Home-based Virtual Reality Training After Stroke

NCT03261713 | Completed

• 1 other identifier: BAMO IF2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

rehabilitation; telerehabilitation; feasibility studies; virtual reality

Outcome Measures

Primary Outcomes (8)

• 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

  18 months

• Quantitative assessment of ability and compliance to research protocol

  assessed by monitoring the use and progression of the VRT program

  18 months

• Qualitative assessment of ability and compliance to research protocol

  assessed through comments made by the participant and study partner

  18 months

• 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

  18 months

• Ability to use VRT in the home

  assessed through comments made by the participant and study partner

  18 months

• Quantitative assessment of acceptability of VRT intervention

  assessed with the Physical Activity Enjoyment Scale

  18 months

• Qualitative assessment of acceptability of VRT intervention

  assessed through comments made by the participant and study partner

  18 months

• Estimate cost for a future definitive RCT

  calculate costs of all components of this study

  18 months

Secondary Outcomes (18)

• Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration

  18 months

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

  18 months

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

  18 months

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

  18 months

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

  18 months

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Virtual reality training designed to train standing balance, reaching, stepping, gentle strengthening and aerobic conditioning.

Device: Virtual reality

Control

ACTIVE COMPARATOR

iPad apps designed to train memory, cognition, visual tracking and fine motor skills.

Device: Control

Interventions

Virtual reality DEVICE

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.

Virtual Reality

Control DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead
• Bruyere Academic Medical Organization: collaborator

Study Sites (1)

Elisabeth Bruyère Hospital

Ottawa, Ontario, K1N 5C8, Canada

Location

Related Publications (2)

• 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.

  PMID: 40153779 DERIVED

• 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.

  PMID: 31174579 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hillel Finestone, MD

  Bruyere Continuing Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor does not know the participant's intervention group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: August 25, 2017
• Study Start: August 16, 2017
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)