Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Training to Increase Rehabilitative Exercise in Seniors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083885
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborators:
York Care Centre
New Brunswick Extra-Mural Program
Bayshore HealthCare
Rocmaura Nursing Home
Carleton Manor Nursing Home
Centre for Innovation and Research in Aging
Nashwaak Villa
Information provided by (Responsible Party):
Lisa Sheehy, Bruyere Research Institute

Brief Summary:
Seniors are at risk for reduced independence and lowered quality of life after injury or illness. Gains in strength, stamina, balance, cardiovascular fitness and confidence resulting from regular exercise can help seniors to maintain (or improve) their functional ability, independence, and quality of life. However, seniors experience many barriers to exercise. The objective is to assess the use of virtual reality (VR) as a motivating way to encourage seniors to do regular rehabilitative exercise. Seniors who are eligible for Extra-Mural rehabilitation for mobility issues and who live in two situations, a) long-term care and b) independently in their homes, will be recruited. Participants will be randomized to usual Extra-Mural rehabilitation (control) or usual Extra-Mural rehabilitation plus VR exercise. Long-term care residents will do VR with the assistance of care staff under the direction of the research team. Independent-living participants will do VR in their homes, under the direction of the research team. All participants will be asked to do VR 3 times a week for 8 weeks. Mobility (balance, gait, physical function), health outcomes (falls, hospital admissions) and health system outcomes (caseload, number of homecare visits) will be assessed and compared over time.

Condition or disease Intervention/treatment Phase
Old Age; Debility Aging Other: Virtual Reality Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-site Prospective randomized open blinded end-point (PROBE) study
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will not know which arm the participants are in. Group allocation will be provided to the research staff member providing the intervention, through use of an online randomization program.
Primary Purpose: Treatment
Official Title: Home-based and Residence-based Virtual Reality Training to Increase Rehabilitative Exercise in Seniors
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Reality
Participants receive 8 weeks of home-based or facility-based virtual reality training, supervised remotely and asynchronously, in addition to their Extra-Mural (homecare) rehabilitation.
Other: Virtual Reality
Participants will be provided with a virtual reality training program, personalized with respect to their abilities, endurance, needs and treatment goals. They will be trained to use the program and it will be installed in their home or provided at their long-term care facility. Participants will be suggested to perform VR 3-5 times a week. Sessions will be 20-30 minutes long, depending on tolerance.

No Intervention: Usual Care
Participants receive their usual Extra-Mural (homecare) rehabilitation.



Primary Outcome Measures :
  1. Functional Reach Test [ Time Frame: Change from baseline to immediately after 8-week intervention ]
    Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.


Secondary Outcome Measures :
  1. Functional Reach Test [ Time Frame: Change from immediately after 8-week intervention to 1 month later ]
    Measures stability by measuring the maximum distance one can reach forward. Longer distance is better.

  2. Berg Balance Scale [ Time Frame: Change from baseline to immediately after 8-week intervention ]
    Measures standing balance and physical function;14 items scored from 0-4 summed for a total out of 56 (higher is better)

  3. Berg Balance Scale [ Time Frame: Change from immediately after 8-week intervention to 1 month later ]
    Measures standing balance and physical function;14 items scored from 0-4 summed for a total out of 56 (higher is better)

  4. Timed Up and Go [ Time Frame: Change from baseline to immediately after 8-week intervention ]
    Measures the time required to rise from a chair, walk 3 m, return and sit down (3 versions, original, manual (carrying a cup of water) and cognitive (count backward in 7's from 99)) Lower time is better.

  5. Timed Up and Go [ Time Frame: Change from immediately after 8-week intervention to 1 month later ]
    Measures the time required to rise from a chair, walk 3 m, return and sit down (3 versions, original, manual (carrying a cup of water) and cognitive (count backward in 7's from 99)) Lower time is better.

  6. Five Times Sit to Stand [ Time Frame: Change from baseline to immediately after 8-week intervention ]
    Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.

  7. Five Times Sit to Stand [ Time Frame: Change from immediately after 8-week intervention to 1 month later ]
    Measures lower extremity strength by timing how long it takes to stand then sit 5 times. Lower time better.

  8. Frenchay Activities Index [ Time Frame: Change from baseline to immediately after 8-week intervention ]
    Measures the frequency of domestic chores, leisure/work and outdoor activities. Scores 15 items from 0-3, summed for a total score out of 45. Higher is better.

  9. Frenchay Activities Index [ Time Frame: Change from immediately after 8-week intervention to 1 month later ]
    Measures the frequency of domestic chores, leisure/work and outdoor activities. Scores 15 items from 0-3, summed for a total score out of 45. Higher is better.

  10. Medical Outcomes Study Short Form 36 (SF-36) [ Time Frame: Change from baseline to immediately after 8-week intervention ]
    Patient report of health status and health-related quality of life. Rates 36 items from 1-3, 1-2, 1-5 or 1-6 and uses "rules" to score each out of 100 and averages them in groups to create scores in 8 different categories (ex. energy/fatigue, emotional well-being). Higher is better.

  11. Medical Outcomes Study Short Form 36 (SF-36) [ Time Frame: Change from immediately after 8-week intervention to 1 month later ]
    Patient report of health status and health-related quality of life. Rates 36 items from 1-3, 1-2, 1-5 or 1-6 and uses "rules" to score each out of 100 and averages them in groups to create scores in 8 different categories (ex. energy/fatigue, emotional well-being). Higher is better.

  12. Feasibility of Virtual Reality [ Time Frame: Immediately after 8-week intervention ]
    Semi-structured Participant and Study Partner Questionnaire interview on enjoyment, perceived usefulness and acceptance of virtual reality, and interest to continue using VR

  13. Falls [ Time Frame: Measured during 8-week intervention ]
    Number of falls

  14. Falls [ Time Frame: Measured during 1-month post-intervention phase ]
    Number of falls

  15. Emergency Room Visits [ Time Frame: Measured during 8-week intervention ]
    Number of emergency room visits

  16. Emergency Room Visits [ Time Frame: Measured during 1-month post-intervention phase ]
    Number of emergency room visits

  17. Hospital Admissions [ Time Frame: Measured during 8-week intervention ]
    Number of admissions to hospital

  18. Hospital Admissions [ Time Frame: Measured during 1-month post-intervention phase ]
    Number of admissions to hospital

  19. Long-term Care Admissions [ Time Frame: Measured during 8-week intervention ]
    Number of admissions to long-term care

  20. Long-term Care Admissions [ Time Frame: Measured during 1-month post-intervention phase ]
    Number of admissions to long-term care

  21. Utilization of Virtual Reality - Days [ Time Frame: Measured during 8-week intervention ]
    Number of days VR was used

  22. Utilization of Virtual Reality - Minutes [ Time Frame: Measured during 8-week intervention ]
    Average number of minutes VR was used during each session

  23. Cost of providing Extra-Mural rehabilitation services [ Time Frame: Change from baseline (week before intervention) to the last week of the 8-week intervention ]
    Cost of providing Extra-Mural rehabilitation services

  24. Therapy Visits [ Time Frame: Change from baseline (week before intervention) to the last week of the 8-week intervention ]
    Number of therapy visits per client by Extra-Mural health care professionals

  25. Caseload Numbers [ Time Frame: Change from baseline (week before intervention) to the last week of the 8-week intervention ]
    Extra-Mural health care professional caseload numbers

  26. Wait-list Length [ Time Frame: Change from baseline (week before intervention) to the last week of the 8-week intervention ]
    Length of wait-lists for Extra-Mural services



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Home-based VR - Eligible are seniors (=> 65 years old) receiving Extra-Mural rehabilitation for mobility issues, as an addition to home-care rehabilitation. Clients must 1) be able to sit or stand without assist (gait aid is fine) for 20 minutes (rest breaks are fine), 2) have sufficient cognitive ability to perform VR, 3) have a project partner, 4) speak and understand French or English, 5) attend 3 sessions at the assessment site or their own home, 6) have enough space in their home, 7) have no health conditions that preclude mild to moderate exercise, 8) live within 50km of the assessment site.

Facility-based VR - Eligible are seniors living in long-term care and receiving rehabilitation or maintenance programs for mobility issues, provided by Extra-Mural therapists and administered by rehabilitation assistants and recreation therapists. Residents must 1) be able to sit or stand without assist (gait aid is fine) for at least 20 minutes (rest breaks are fine), 2) have sufficient cognitive ability to perform VR, 3) speak and understand French or English, 4) have no health conditions that preclude mild exercise.

Exclusion Criteria:

Patients will be excluded if they have an unstable medical condition, seizures or vertigo.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083885


Contacts
Layout table for location contacts
Contact: Alana Gullison 01-506-444-3880 AGullison@ycc-cira.ca
Contact: Justine Henry 01-506-444-3880 ext 2562 JHenry@ycc-cira.ca

Locations
Layout table for location information
Canada, New Brunswick
York Care Centre Recruiting
Fredericton, New Brunswick, Canada, E3A 1A3
New Brunswick Extra-Mural Program Recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Rocmaura Nursing Home Recruiting
Saint John, New Brunswick, Canada, E2K 4P1
Nashwaak Villa Recruiting
Stanley, New Brunswick, Canada, E6B 1E9
Contact: Melody O'Neill    506-367-7733    don@nashwaakvilla.ca   
Carleton Manor Nursing Home Recruiting
Woodstock, New Brunswick, Canada, E7M 5G6
Sponsors and Collaborators
Bruyere Research Institute
York Care Centre
New Brunswick Extra-Mural Program
Bayshore HealthCare
Rocmaura Nursing Home
Carleton Manor Nursing Home
Centre for Innovation and Research in Aging
Nashwaak Villa
Investigators
Layout table for investigator information
Principal Investigator: Lisa Sheehy, PhD Bruyere Research Institute
Additional Information:
Publications of Results:
Sheehy L, Chapman I, Sveistrup H, Yang C, Bilodeau M, Finestone H. Home-based virtual reality training after stroke: preliminary data of a telerehabilitation feasibility randomized controlled trial. International Journal of Stroke 13(2S):207, 2018.

Other Publications:
Layout table for additonal information
Responsible Party: Lisa Sheehy, Research Associate, Bruyere Research Institute
ClinicalTrials.gov Identifier: NCT04083885    
Other Study ID Numbers: M16-19-026
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Sheehy, Bruyere Research Institute:
rehabilitation
virtual reality
telerehabilitation
technology