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

Not Applicable
Completed
Conditions
Stroke
Interventions
Behavioral: Tai Chi based exercise program
Registration Number
NCT01848080
Lead Sponsor
Université de Sherbrooke
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
142
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tai chi program via home visitsTai Chi based exercise programAn 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.
Tai chi program via TelerehabilitationTai Chi based exercise programAn 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.
Primary Outcome Measures
NameTimeMethod
Change from baseline in mobility at 2 and 4 monthsbefore the intervention, month 2 and month 4

Community balance and mobility Scale.

Change from baseline in Balance at 2 and 4 monthsbefore the intervention, month 2 and month 4

Community balance and mobility Scale.

Secondary Outcome Measures
NameTimeMethod
Change from baseline aptitude for Balance at 2 and 4 monthsbefore the intervention, month 2 and month 4

Four-Squares Test

Change from baseline walking speed at 2 and 4 monthsbefore the intervention, month 2, month 4

Speed: Timed up and go (TUG),

Change from Baseline Satisfaction with the care received at 2 and 4 monthsbefore the intervention, month 2, month 4

Satisfaction with the care received = Health care satisfaction questionnaire

Change from baseline Quality of life at 2 and 4 monthbefore the intervention, month 2, month 4

Quality of life: Reintegration ti normal Living Index (RNLI)

Change from baseline walking endurance at 2 and 4 monthsbefore the intervention, month 2 and month 4

distance in meters walked two minutes

Change from baseline Psychological Attitudes related to mobility at 2 and 4 monthsbefore the intervention, month 2, month 4

fear of falling: Activities-specific Balance confidence scale

Change from baseline Psychological Attitudes related to balance at 2 and 4 monthsbefore the intervention, month 2, month 4

Self efficacy: General Perceived Self efficacy

Change from Baseline Cost of services from the perspective of the health system at 2 and 4 monthsbefore the intervention, month 2, month 4

Cost of services from the perspective of the health system = "Cost-analysis of telemedicine" from the Minnesota University

Change from baseline Strength of lower limbs at 2 and 4 monthsbefore the intervention, month 2 and month 4

Sit to Stand Test

Trial Locations

Locations (3)

Hôpital Charles-LeMoyne

🇨🇦

Longueuil, Canada

Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain

🇨🇦

Montréal, Canada

Research Centre on Aging

🇨🇦

Sherbrooke, Canada

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