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Completed

NCT Number: NCT01848080

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Charles-LeMoyne, Longueuil, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi based exercise program

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • University of Toronto
  • Université de Montréal

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
May 7, 2013
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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