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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tai Chi based exercise program
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Telemedicine, Telerehabilitation, Acute Stroke, Tai Chi, Tai Ji, Rehabilitation, Home care services, Single blind method, Randomized controlled trial

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Charles-LeMoyne
  • Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
  • Research Centre on Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tai chi program via Telerehabilitation

Tai chi program via home visits

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in mobility at 2 and 4 months
Community balance and mobility Scale.
Change from baseline in Balance at 2 and 4 months
Community balance and mobility Scale.

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2013
Last Updated
September 27, 2021
Sponsor
Université de Sherbrooke
Collaborators
Université de Montréal, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01848080
Brief Title
A Randomized, Non-inferiority Clinical Trial of CVA Telerehabilitation Treatments - TelePhysioTaiChi
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Université de Montréal, University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Telemedicine, Telerehabilitation, Acute Stroke, Tai Chi, Tai Ji, Rehabilitation, Home care services, Single blind method, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai chi program via Telerehabilitation
Arm Type
Experimental
Arm 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 Title
Tai chi program via home visits
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi based exercise program
Intervention Description
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 Measure Information:
Title
Change from baseline in mobility at 2 and 4 months
Description
Community balance and mobility Scale.
Time Frame
before the intervention, month 2 and month 4
Title
Change from baseline in Balance at 2 and 4 months
Description
Community balance and mobility Scale.
Time Frame
before the intervention, month 2 and month 4
Secondary Outcome Measure Information:
Title
Change from baseline walking speed at 2 and 4 months
Description
Speed: Timed up and go (TUG),
Time Frame
before the intervention, month 2, month 4
Title
Change from baseline Psychological Attitudes related to balance at 2 and 4 months
Description
Self efficacy: General Perceived Self efficacy
Time Frame
before the intervention, month 2, month 4
Title
Change from baseline Quality of life at 2 and 4 month
Description
Quality of life: Reintegration ti normal Living Index (RNLI)
Time Frame
before the intervention, month 2, month 4
Title
Change from Baseline Satisfaction with the care received at 2 and 4 months
Description
Satisfaction with the care received = Health care satisfaction questionnaire
Time Frame
before the intervention, month 2, month 4
Title
Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months
Description
Cost of services from the perspective of the health system = "Cost-analysis of telemedicine" from the Minnesota University
Time Frame
before the intervention, month 2, month 4
Title
Change from baseline walking endurance at 2 and 4 months
Description
distance in meters walked two minutes
Time Frame
before the intervention, month 2 and month 4
Title
Change from baseline aptitude for Balance at 2 and 4 months
Description
Four-Squares Test
Time Frame
before the intervention, month 2 and month 4
Title
Change from baseline Strength of lower limbs at 2 and 4 months
Description
Sit to Stand Test
Time Frame
before the intervention, month 2 and month 4
Title
Change from baseline Psychological Attitudes related to mobility at 2 and 4 months
Description
fear of falling: Activities-specific Balance confidence scale
Time Frame
before the intervention, month 2, month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Tousignant, PhD
Organizational Affiliation
Research Centre on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Charles-LeMoyne
City
Longueuil
Country
Canada
Facility Name
Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
City
Montréal
Country
Canada
Facility Name
Research Centre on Aging
City
Sherbrooke
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24479760
Citation
Tousignant M, Corriveau H, Kairy D, Berg K, Dubois MF, Gosselin S, Swartz RH, Boulanger JM, Danells C. Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial. Trials. 2014 Jan 30;15:42. doi: 10.1186/1745-6215-15-42.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3912257/pdf/1745-6215-15-42.pdf
Description
Complete and published research protocol

Learn more about this trial

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

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