Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home

Université de Montréal

Status: Completed

Conditions: Stroke

Treatments: Other: Telerehabilitation system

Study type: Interventional

Funder types: Other

Identifiers

NCT02491203

CRIR-937-0214

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 (Richard, 2013) 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 a TR system that allows upper limb rehabilitation with ongoing off-line monitoring, to be used after usual poststroke rehabilitation is completed and services are no longer offered.

Full description

More specifically, the objective of the proposed study is to assess the impact, in terms of motor recovery, function,quality of life, compliance, safety and cost, of a novel, patient-centered home-based tailored TR program using an affordable virtual reality system for upper-limb rehabilitation post-stroke. Such a system, combined with remote off-line monitoring could allow patients to take charge and pursue their rehabilitation beyond current services, maximizing their potential for recovery.

A single-blind two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 4-week training with home-based tele-rehabilitation (TR) system (see intervention below).i.e. treatment group or (2) 4-week written home exercise program provided by a clinician, i.e. exercise control group.

Enrollment: 52 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 3-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
• At least 6 months post stroke;
• No longer receiving rehabilitation services; and (5) 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;
• 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

Usual care

No Intervention group

Description:

All study participants in the control group will receive a 4-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.

Telerehabilitation system

Experimental group

Description:

Participants in the experimental group will receive four weeks written home exercise program provided by a clinician, i.e. usual care discharge home program plus 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 the program adapted to ensure it remains at an appropriate level for the patient.

Treatment:

Other: Telerehabilitation system