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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03759106
Other study ID # CRIR-1319-0218
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 27, 2019
Est. completion date December 2023

Study information

Verified date November 2022
Source Université de Montréal
Contact Alejandro Hernandez, MSc
Phone 514-340-2085
Email alejandro.hernandez@mail.mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date December 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
home written exercise program
exercises such as picking up objects, placing objects, frequently prescribed at discharge
telerehabilitation/exergame system
Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing

Locations

Country Name City State
Canada Université de Montréal Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Université de Montréal Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE) Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary 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 The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores. baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test The Wolf Motor Function test consists of tasks that are performed by the participant with the impaired upper extremity, the tasks are rated for the quality of movement and the time taken. Items are scored on a 6 point scale, from does not attempt to movement is normal. Times tests are truncated at 120 seconds. A mean score out of a maximum of 5 is calculated. baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary number of sessions (feasibility) number of sessions played (count) 8 weeks (ongoing)
Secondary duration of sessions (Feasibility) average duration of sessions played (minutes) 8 weeks (ongoing)
Secondary Amount of time spent on the actual exe games (moving the arm) amount of actual time spent using the impaired arm during the sessions (minutes) 8 weeks (ongoing)
Secondary Frequency of on-line consultations with therapist Number of times real-time sessions are held between the therapist and the participant (online) 8 weeks (ongoing)
Secondary duration (minutes) of on-line consultations with therapist average time spent by the therapist assisting for real-time sessions 8 weeks (ongoing)
Secondary adverse event (counts) occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session. 8 weeks (ongoing)
Secondary falls (count) occurrence of falls documented by the participant 8 weeks (ongoing)
Secondary adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion) self perceived exertion rated by the participant after the session (i.e. playing the exergame) on a scale 6-20, (no exertion to maximal exertion) 8 weeks (ongoing)
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