Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach

Université de Montréal

Status: Enrolling

Conditions: Stroke

Treatments: Other: home written exercise program; Other: telerehabilitation/exergame system

Study type: Interventional

Funder types: Other

Identifiers

NCT03759106

CRIR-1319-0218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

No Intervention: Usual care

Other group

Description:

All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.

Treatment:

Other: home written exercise program

Experimental: Telerehabilitation system

Experimental group

Description:

Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient.

Treatment:

Other: telerehabilitation/exergame system