Stroke
Conditions
Keywords
Virtual reality, telerehabilitation, Stroke rehabilitation
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.
Interventions
OTHERhome written exercise program
exercises such as picking up objects, placing objects, frequently prescribed at discharge
OTHERtelerehabilitation/exergame system
Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
Sponsors
Canadian Institutes of Health Research (CIHR)
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE) | baseline and eight weeks after intervention, as well as 1 and 2 month follow up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration (minutes) of on-line consultations with therapist | 8 weeks (ongoing) | average time spent by the therapist assisting for real-time sessions |
| duration of sessions (Feasibility) | 8 weeks (ongoing) | average duration of sessions played (minutes) |
| Amount of time spent on the actual exe games (moving the arm) | 8 weeks (ongoing) | amount of actual time spent using the impaired arm during the sessions (minutes) |
| Frequency of on-line consultations with therapist | 8 weeks (ongoing) | Number of times real-time sessions are held between the therapist and the participant (online) |
| 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 | baseline and eight weeks after intervention, as well as 1 and 2 month follow up | 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. |
| Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test | baseline and eight weeks after intervention, as well as 1 and 2 month follow up | 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. |
| number of sessions (feasibility) | 8 weeks (ongoing) | number of sessions played (count) |
| adverse event (counts) | 8 weeks (ongoing) | occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session. |
| falls (count) | 8 weeks (ongoing) | occurrence of falls documented by the participant |
| adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion) | 8 weeks (ongoing) | 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) |
Countries
Canada
Contacts
Primary ContactAlejandro Hernandez, MSc
Backup ContactDahlia Kairy, phd
Outcome results
None listed