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

Recruiting

Phase N/A Results N/A

Trial Description

In Canada, only 10 to 15% of individuals following a cerebral vascular accident (CVA) receive intensive rehabilitation services. The majority of individuals return home with or without rehabilitation services, as outpatient services are unable to meet the demand. Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home. The main hypothesis is: The participants who received the intervention via telerehabilitation will have a gain in their Community Balance and Mobility Scale (CB&M) score that will not be inferior to the gain observed in participants who received the intervention via home visits (less than 4 points). The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits. The secondary hypotheses are: Two to four months following discharge from hospital, the investigators hypothesize that the level of: 1) gain in physical and psychological capacities related to mobility; 2) gain in the quality of life, and 3) satisfaction of services received will not be inferior in the TELE group compared to the VISIT group and that 4) the Tele approach will be more cost-effective compared to the VISIT approach. 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. Participants will be recruited during the hospitalization period at each of the three sites. The investigators expect to recruit 240 participants, 120 per group. All evaluations will be completed in the research centers/hospitals of the three sites and will last approximately 1.5 hours. The first evaluation will be conducted prior to hospital discharge (T1) to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following discharge from hospital. The independent variable is individualized exercise program, based on Tai Chi. The dependant variables are Balance, functional mobility, physical capacities, psychological capacities related to mobility and balance, quality of life, satisfaction with care received, cost of services according to the healthcare system. The difference between the two groups will then be compared using a t-test. The economic analysis will be a type of cost-effectiveness.

Conditions

Interventions

  • Tai Chi based exercise program Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Tai chi program via Telerehabilitation
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Tai chi program via home visits
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in mobility at 2 and 4 months before the intervention, month 2 and month 4 No
Primary Change from baseline in Balance at 2 and 4 months before the intervention, month 2 and month 4 No
Secondary Change from baseline walking speed at 2 and 4 months before the intervention, month 2, month 4 No
Secondary Change from baseline Psychological Attitudes related to balance at 2 and 4 months before the intervention, month 2, month 4 No
Secondary Change from baseline Quality of life at 2 and 4 month before the intervention, month 2, month 4 No
Secondary Change from Baseline Satisfaction with the care received at 2 and 4 months before the intervention, month 2, month 4 No
Secondary Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months before the intervention, month 2, month 4 No
Secondary Change from baseline walking endurance at 2 and 4 months before the intervention, month 2 and month 4 No
Secondary Change from baseline aptitude for Balance at 2 and 4 months before the intervention, month 2 and month 4 No
Secondary Change from baseline Strength of lower limbs at 2 and 4 months before the intervention, month 2 and month 4 No
Secondary Change from baseline Psychological Attitudes related to mobility at 2 and 4 months before the intervention, month 2, month 4 No

Sponsors