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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01848080
Enrollment
142
Registered
2013-05-07
Start date
2013-06-30
Completion date
2021-09-16
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Telemedicine, Telerehabilitation, Acute Stroke, Tai Chi, Tai Ji, Rehabilitation, Home care services, Single blind method, Randomized controlled trial

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.

Interventions

BEHAVIORALTai 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.

Sponsors

Université de Montréal
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in mobility at 2 and 4 monthsbefore the intervention, month 2 and month 4Community balance and mobility Scale.
Change from baseline in Balance at 2 and 4 monthsbefore the intervention, month 2 and month 4Community balance and mobility Scale.

Secondary

MeasureTime frameDescription
Change from baseline Quality of life at 2 and 4 monthbefore the intervention, month 2, month 4Quality of life: Reintegration ti normal Living Index (RNLI)
Change from Baseline Satisfaction with the care received at 2 and 4 monthsbefore the intervention, month 2, month 4Satisfaction 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 monthsbefore the intervention, month 2, month 4Cost of services from the perspective of the health system = Cost-analysis of telemedicine from the Minnesota University
Change from baseline walking speed at 2 and 4 monthsbefore the intervention, month 2, month 4Speed: Timed up and go (TUG),
Change from baseline aptitude for Balance at 2 and 4 monthsbefore the intervention, month 2 and month 4Four-Squares Test
Change from baseline Strength of lower limbs at 2 and 4 monthsbefore the intervention, month 2 and month 4Sit to Stand Test
Change from baseline Psychological Attitudes related to mobility at 2 and 4 monthsbefore the intervention, month 2, month 4fear of falling: Activities-specific Balance confidence scale
Change from baseline walking endurance at 2 and 4 monthsbefore the intervention, month 2 and month 4distance in meters walked two minutes
Change from baseline Psychological Attitudes related to balance at 2 and 4 monthsbefore the intervention, month 2, month 4Self efficacy: General Perceived Self efficacy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026