A Randomized, Non-inferiority Clinical Trial of CVA Telerehabilitation Treatments - TelePhysioTaiChi

Study Overview
=================
Brief Summary
-----------------
Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.

Official Title
-----------------
A Tai Chi Based Exercise Program Provided Via Telerehabilitation Compared to During Home Visits in Persons Post-Stroke Who Have Returned Home Without Intensive Rehabilitation: A Randomized, Non-inferiority Clinical Trial

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Tai Chi based exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have had a stroke with a Rankin score of 2 or 3; was not referred to an Intensive Functional Rehabilitation Unit (IFRU) and returned home following discharge from hospital; understands instructions to allow participation in evaluations and interventions; has a balance problem as evidenced by a score between 46 and 54 on the Berg Balance Scale96; has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises; live in an area serviced by high speed Internet. Exclusion Criteria: severe body hemineglect; significant hemianopsia visual problems accompanied by hemineglect; uncontrolled medical problems; moderate to severe aphasia

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai chi program via Telerehabilitation<br>An individualized exercise program, based on Tai Chi, was developed by our team for previous studies aiming to improve balance in elderly, diabetic individuals and in frail, elderly individuals with balance problems. The exercise program consists of movements based on a combination of alignments and body-specific orientations, weight transfers and changes in direction inspired by Tai Chi. This group will receive this program via telerehabilitation. | Behavioral: Tai Chi based exercise program<br>* A Tai Chi based exercise program that uses movement repetition favoring directional adjustments in space, supervised by a physiotherapist, has been shown to be effective in improving balance in individuals with physical impairments, including those presenting with sequelae following a stroke.<br>|
| Active Comparator: Tai chi program via home visits<br>An individualized exercise program, based on Tai Chi, was developed by our team for previous studies aiming to improve balance in elderly, diabetic individuals and in frail, elderly individuals with balance problems. The exercise program consists of movements based on a combination of alignments and body-specific orientations, weight transfers and changes in direction inspired by Tai Chi. This group will receive this program via home visits. | Behavioral: Tai Chi based exercise program<br>* A Tai Chi based exercise program that uses movement repetition favoring directional adjustments in space, supervised by a physiotherapist, has been shown to be effective in improving balance in individuals with physical impairments, including those presenting with sequelae following a stroke.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mobility at 2 and 4 months | Community balance and mobility Scale. | before the intervention, month 2 and month 4 | 
| Change from baseline in Balance at 2 and 4 months | Community balance and mobility Scale. | before the intervention, month 2 and month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline walking speed at 2 and 4 months | Speed: Timed up and go (TUG), | before the intervention, month 2, month 4 | 
| Change from baseline Psychological Attitudes related to balance at 2 and 4 months | Self efficacy: General Perceived Self efficacy | before the intervention, month 2, month 4 | 
| Change from baseline Quality of life at 2 and 4 month | Quality of life: Reintegration ti normal Living Index (RNLI) | before the intervention, month 2, month 4 | 
| Change from Baseline Satisfaction with the care received at 2 and 4 months | Satisfaction with the care received = Health care satisfaction questionnaire | before the intervention, month 2, month 4 | 
| Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months | Cost of services from the perspective of the health system = Cost-analysis of telemedicine from the Minnesota University | before the intervention, month 2, month 4 | 
| Change from baseline walking endurance at 2 and 4 months | distance in meters walked two minutes | before the intervention, month 2 and month 4 | 
| Change from baseline aptitude for Balance at 2 and 4 months | Four-Squares Test | before the intervention, month 2 and month 4 | 
| Change from baseline Strength of lower limbs at 2 and 4 months | Sit to Stand Test | before the intervention, month 2 and month 4 | 
| Change from baseline Psychological Attitudes related to mobility at 2 and 4 months | fear of falling: Activities-specific Balance confidence scale | before the intervention, month 2, month 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Telerehabilitation, Acute Stroke, Tai Chi, Tai Ji, Rehabilitation, Home care services, Single blind method, Randomized controlled trial