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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Université de Sherbrooke
Sponsor:
Collaborators:
Université de Montréal
University of Toronto
Information provided by (Responsible Party):
Michel Tousignant, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01848080
First received: April 26, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Tai Chi based exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Change from baseline in mobility at 2 and 4 months [ Time Frame: before the intervention, month 2 and month 4 ] [ Designated as safety issue: No ]
    Community balance and mobility Scale.

  • Change from baseline in Balance at 2 and 4 months [ Time Frame: before the intervention, month 2 and month 4 ] [ Designated as safety issue: No ]
    Community balance and mobility Scale.


Secondary Outcome Measures:
  • Change from baseline walking speed at 2 and 4 months [ Time Frame: before the intervention, month 2, month 4 ] [ Designated as safety issue: No ]
    Speed: Timed up and go (TUG),

  • Change from baseline Psychological Attitudes related to balance at 2 and 4 months [ Time Frame: before the intervention, month 2, month 4 ] [ Designated as safety issue: No ]
    Self efficacy: General Perceived Self efficacy

  • Change from baseline Quality of life at 2 and 4 month [ Time Frame: before the intervention, month 2, month 4 ] [ Designated as safety issue: No ]
    Quality of life: Reintegration ti normal Living Index (RNLI)

  • Change from Baseline Satisfaction with the care received at 2 and 4 months [ Time Frame: before the intervention, month 2, month 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: before the intervention, month 2, month 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: before the intervention, month 2 and month 4 ] [ Designated as safety issue: No ]
    distance in meters walked two minutes

  • Change from baseline aptitude for Balance at 2 and 4 months [ Time Frame: before the intervention, month 2 and month 4 ] [ Designated as safety issue: No ]
    Four-Squares Test

  • Change from baseline Strength of lower limbs at 2 and 4 months [ Time Frame: before the intervention, month 2 and month 4 ] [ Designated as safety issue: No ]
    Sit to Stand Test

  • Change from baseline Psychological Attitudes related to mobility at 2 and 4 months [ Time Frame: before the intervention, month 2, month 4 ] [ Designated as safety issue: No ]
    fear of falling: Activities-specific Balance confidence scale


Estimated Enrollment: 240
Study Start Date: June 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848080

Locations
Canada, Quebec
Research Center on Aging Recruiting
Sherbrooke, Quebec, Canada, J1H 4C4
Contact: Michel Tousignant, Ph.D.    819-780-2220 ext 45351    michel.tousignant@usherbrooke.ca   
Principal Investigator: Michel Tousignant, Ph.D.         
Sponsors and Collaborators
Université de Sherbrooke
Université de Montréal
University of Toronto
  More Information

No publications provided by Université de Sherbrooke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Tousignant, Professor, PH.D., Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01848080     History of Changes
Other Study ID Numbers: 10-217-S1
Study First Received: April 26, 2013
Last Updated: July 17, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by 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:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014