Virtual Reality Exercise for Stroke Rehabilitation in Inpatients Who Are Unable to Stand

NCT02285933 | Completed

• 1 other identifier: G-14-0005830
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients.

Conditions

Stroke

Keywords

stroke; physical therapy specialty; exercise therapy; virtual reality; man-machine systems; randomized control trial; inpatients; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions

  assesses static, dynamic and reactional sitting balance

  baseline, immediately after 10-12 treatments

• Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment

  assesses static, dynamic and reactional sitting balance

  baseline,1 month after second assessment

Secondary Outcomes (17)

• Change in the Ottawa Sitting Scale (OSS) from baseline to after 10-12 treatment sessions

  baseline, immediately after 10-12 treatments

• Change in the Ottawa Sitting Scale (OSS) from baseline to 1 month after second assessment

  baseline, 1 month after second assement

• Change in Limits of stability in sitting (LoS) from baseline to after 10-12 treatment sessions

  before treatment, immediately after 10-12 treatments

• Change in Limits of stability in sitting (LoS) from baseline to 1 month after second assessment

  baseline, 1 month after second assement

• Change in Postural sway in sitting from baseline to after 10-12 treatment sessions

  baseline, immediately after 10-12 treatments

Study Arms (2)

VRT

EXPERIMENTAL

sitting balance exercises delivered via virtual reality training

Other: virtual reality training

control

ACTIVE COMPARATOR

virtual reality training requiring limited arm movements and no challenge to sitting balance

Other: control

Interventions

virtual reality training OTHER

Each participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Exercises challenge sitting balance control, reaching and shifting the base of support; for example, controlling a ball as it rolls down a maze or reaching to put dishes away in a virtual kitchen. The difficulty of the games is monitored to maintain a challenge to sitting balance. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre of pressure to ensure that the participant is adequately challenged during the VRT.

VRT

control OTHER

Each participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Control group exercises require limited hand and arm movements; for example, using an arm to move a fish along a simple pathway or using the arms to pop balloons without reaching. Control group participants are strapped into their chair to minimize trunk movement. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre during the VRT.

control

Eligibility Criteria

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

You may qualify if:

• ischemic or hemorrhagic stroke in the left or right cortical or subcortical regions
• medically stable
• cannot stand independently for \>1 minute or cannot stand at all
• can sit for at least 20 minutes with or without trunk support and can sit for at least 1 minute without trunk support
• able to provide informed consent

You may not qualify if:

• unstable cardiovascular, respiratory, endocrine, orthopedic or neurological condition that precludes exercise of low to moderate intensity
• vestibular deficits or vertigo
• seizure activity in the previous 6 months

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead
• Ottawa Hospital Research Institute: collaborator
• University of Ottawa: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Elisabeth Bruyere Hospital

Ottawa, Ontario, K1N 5C8, Canada

Location

Related Publications (4)

• McEwen D, Taillon-Hobson A, Bilodeau M, Sveistrup H, Finestone H. Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial. Stroke. 2014 Jun;45(6):1853-5. doi: 10.1161/STROKEAHA.114.005362. Epub 2014 Apr 24.

  PMID: 24763929 BACKGROUND

• Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Fergusson D, Levac D, Finestone H. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial. BMC Neurol. 2016 Mar 31;16:42. doi: 10.1186/s12883-016-0563-x.

  PMID: 27036515 BACKGROUND

• Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Finestone H. Implementation of a randomized controlled trial on an inpatient stroke rehabilitation unit: Lessons learned. Contemp Clin Trials Commun. 2020 Apr 6;18:100563. doi: 10.1016/j.conctc.2020.100563. eCollection 2020 Jun.

  PMID: 32617429 DERIVED

• Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Yang C, Finestone H. Sitting Balance Exercise Performed Using Virtual Reality Training on a Stroke Rehabilitation Inpatient Service: A Randomized Controlled Study. PM R. 2020 Aug;12(8):754-765. doi: 10.1002/pmrj.12331. Epub 2020 Feb 21.

  PMID: 31970898 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 M Finestone, MD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

• Heidi Sveistrup, PhD

  University of Ottawa

  STUDY DIRECTOR

• Martin Bilodeau, PhD

  University of Ottawa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Stroke Rehabilitation Research

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 7, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 30, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)