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

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ClinicalTrials.gov Identifier: NCT01848080
Recruitment Status : Recruiting
First Posted : May 7, 2013
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Université de Montréal
University of Toronto
Information provided by (Responsible Party):
Michel Tousignant, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Tai Chi based exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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),

  2. 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

  3. 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)

  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

  5. 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

  6. 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

  7. Change from baseline aptitude for Balance at 2 and 4 months [ Time Frame: before the intervention, month 2 and month 4 ]
    Four-Squares Test

  8. 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

  9. 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



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848080


Contacts
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Contact: Catherine Pagé 819-780-2220 ext 45421 catherine.page@usherbrooke.ca

Locations
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Canada
Hôpital Charles-LeMoyne Recruiting
Longueuil, Canada
Contact: Christel Simard       christel.simard.cisssmc16@ssss.gouv.qc.ca   
Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain Recruiting
Montréal, Canada
Contact: Dahlia Kairy       dahlia.kairy@umontreal.ca   
Research Centre on Aging Recruiting
Sherbrooke, Canada
Contact: Catherine Pagé    819-780-2220 ext 45421    catherine.page@usherbrooke.ca   
Sponsors and Collaborators
Université de Sherbrooke
Université de Montréal
University of Toronto
Investigators
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Principal Investigator: Michel Tousignant, PhD Research Centre on Aging

Additional Information:
Publications:
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Responsible Party: Michel Tousignant, Professor, PH.D., Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01848080     History of Changes
Other Study ID Numbers: 10-217-S1
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

Keywords provided by Michel Tousignant, Université de Sherbrooke:
Telemedicine
Telerehabilitation
Acute Stroke
Tai Chi
Tai Ji
Rehabilitation
Home care services
Single blind method
Randomized controlled trial

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases