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

Université de Sherbrooke

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Tai Chi based exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT01848080

10-217-S1

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 45+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Tai chi program via Telerehabilitation

Experimental group

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.

Treatment:

Behavioral: Tai Chi based exercise program

Tai chi program via home visits

Active Comparator group

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.

Treatment:

Behavioral: Tai Chi based exercise program