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

September 27, 2021 updated by: Michel Tousignant, Université de Sherbrooke

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Longueuil, Canada
        • Hopital Charles-LeMoyne
      • Montréal, Canada
        • Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
      • Sherbrooke, Canada
        • Research Centre on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tai chi program via Telerehabilitation
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
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.
Active Comparator: Tai chi program via home visits
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mobility at 2 and 4 months
Time Frame: before the intervention, month 2 and month 4
Community balance and mobility Scale.
before the intervention, month 2 and month 4
Change from baseline in Balance at 2 and 4 months
Time Frame: before the intervention, month 2 and month 4
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
Time Frame: before the intervention, month 2, month 4
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
Time Frame: before the intervention, month 2, month 4
Self efficacy: General Perceived Self efficacy
before the intervention, month 2, month 4
Change from baseline Quality of life at 2 and 4 month
Time Frame: before the intervention, month 2, month 4
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
Time Frame: before the intervention, month 2, month 4
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
Time Frame: before the intervention, month 2, month 4
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
Time Frame: before the intervention, month 2 and month 4
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
Time Frame: before the intervention, month 2 and month 4
Four-Squares Test
before the intervention, month 2 and month 4
Change from baseline Strength of lower limbs at 2 and 4 months
Time Frame: before the intervention, month 2 and month 4
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
Time Frame: before the intervention, month 2, month 4
fear of falling: Activities-specific Balance confidence scale
before the intervention, month 2, month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

University of Toronto
Université de Montréal

Investigators

  • Principal Investigator: Michel Tousignant, PhD, Research Centre on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-217-S1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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