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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2021-09-16

Brief Summary

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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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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tai Chi based exercise program

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Tai Chi based exercise program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No