Clinical trial NCT01848080: A Randomized, Non-inferiority Clinical Trial of CVA Telerehabilitation Treatments - TelePhysioTaiChi
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Telemedicine
Telerehabilitation
Acute Stroke
Tai Chi
Tai Ji
Rehabilitation
Home care services
Single blind method
Randomized controlled trial
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: University of Toronto
First posted: 2013-05-07
Enrollment: 142
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mobility at 2 and 4 months
timeFrame: before the intervention, month 2 and month 4
measure: Change from baseline in Balance at 2 and 4 months
timeFrame: before the intervention, month 2 and month 4
Secondary outcomes:
measure: Change from baseline walking speed at 2 and 4 months
timeFrame: before the intervention, month 2, month 4
measure: Change from baseline Psychological Attitudes related to balance at 2 and 4 months
timeFrame: before the intervention, month 2, month 4
measure: Change from baseline Quality of life at 2 and 4 month
timeFrame: before the intervention, month 2, month 4
measure: Change from Baseline Satisfaction with the care received at 2 and 4 months
timeFrame: before the intervention, month 2, month 4
measure: Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months
timeFrame: before the intervention, month 2, month 4
measure: Change from baseline walking endurance at 2 and 4 months
timeFrame: before the intervention, month 2 and month 4
measure: Change from baseline aptitude for Balance at 2 and 4 months
timeFrame: before the intervention, month 2 and month 4
measure: Change from baseline Strength of lower limbs at 2 and 4 months
timeFrame: before the intervention, month 2 and month 4
measure: Change from baseline Psychological Attitudes related to mobility at 2 and 4 months
timeFrame: before the intervention, month 2, month 4
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: Hôpital Charles-LeMoyne
city: Montréal
country: Canada
facility: Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
city: Sherbrooke
country: Canada
facility: Research Centre on Aging
Study officials:
affiliation: Research Centre on Aging
name: Michel Tousignant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tousignant M, Corriveau H, Kairy D, Berg K, Dubois MF, Gosselin S, Swartz RH, Boulanger JM, Danells C. Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial. Trials. 2014 Jan 30;15:42. doi: 10.1186/1745-6215-15-42.