Clinical trial NCT03759106: Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
Official title: Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Virtual reality
telerehabilitation
Stroke rehabilitation
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-11-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec. Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, the investigators have developed and propose to examine the use of the VirTele system for people who have suffered a stroke who are no longer receiving rehabilitation services The VirTele system allows upper limb rehabilitation using exergames with ongoing off-line monitoring combined with online monitoring and coaching based on the self-determination theory.

Detailed description: More specifically, the primary objective of the RCT is to provide preliminary evidence regarding efficacy of the VirTele program for upper limb motor control recovery in chronic stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper limb function, quality of life and motivation; ii. Determine the feasibility of using the VirTele program with users at home (e.g. adherence, safety, technical difficulties, facilitators and barriers); iii. Explore the role that shared decision-making and empowerment play in exercise program adherence and progression, and in behavior modification for upper-limb use.

This study will also provide evidence of feasibility for conducting a larger-scale RCT comparing different technologies and interventions for chronic stroke rehabilitation.

A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 8-week training with the VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a clinician (GRASP), i.e. exercise control group.

Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
* Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
* No longer receiving rehabilitation services;
* living in an area where high speed Internet access is available.

Exclusion Criteria:

* Being medically unstable;
* Severe cognitive or communication deficits;
* Visual impairments;
* Severe balance deficits limiting sitting safely independently;
* Shoulder pain limiting movements for the game;
* Previous upper limb impairment limiting potential recovery.

Primary outcomes:
measure: Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
timeFrame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary outcomes:
measure: Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
timeFrame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
measure: Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
timeFrame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
measure: number of sessions (feasibility)
timeFrame: 8 weeks (ongoing)
measure: duration of sessions (Feasibility)
timeFrame: 8 weeks (ongoing)
measure: Amount of time spent on the actual exe games (moving the arm)
timeFrame: 8 weeks (ongoing)
measure: Frequency of on-line consultations with therapist
timeFrame: 8 weeks (ongoing)
measure: duration (minutes) of on-line consultations with therapist
timeFrame: 8 weeks (ongoing)
measure: adverse event (counts)
timeFrame: 8 weeks (ongoing)
measure: falls (count)
timeFrame: 8 weeks (ongoing)
measure: adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
timeFrame: 8 weeks (ongoing)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Dahlia Kairy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allegue DR, Kairy D, Higgins J, Archambault P, Michaud F, Miller W, Sweet SN, Tousignant M. Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2020 May 21;9(5):e14629. doi: 10.2196/14629.