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.
BACKGROUND
The incidence of strokes in industrialized nations is on the rise, particularly in the older population. In Canada, a minority of individuals who have had a stroke actually receive intensive rehabilitation because most stroke patients do not have access to services or because their motor recovery was judged adequate to return home. Thus, there is a considerable need to organize home-based rehabilitation services for everyone who has had a stroke. To meet this demand, telerehabilitation, particularly from a service center to the patient's home, is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home.


METHODS
This non-inferiority study will include patients who have returned home post-stroke without requiring intensive rehabilitation. To be included in the study, participants will: 1) not be referred to an Intensive Functional Rehabilitation Unit, 2) have a Rankin score of 2 or 3, and 3) have a balance problem (Berg Balance Scale score between 46 and 54). Participants will be randomly assigned to either the teletreatment group or the home visits group. Except for the delivery mode, the intervention will be the same for both groups, that is, a personalized Tai Chi-based exercise program conducted by a trained physiotherapist (45-minute session twice a week for eight consecutive weeks). The main objective of this research is to test the non-inferiority of a Tai Chi-based exercise program provided via telerehabilitation compared to the same program provided in person at home in terms of effectiveness for retraining balance in individuals who have had a stroke but do not require intensive functional rehabilitation. The main outcome of this study is balance and mobility measured with the Community Balance and Mobility Scale. Secondary outcomes include physical and psychological capacities related to balance and mobility, participants' quality of life, satisfaction with services received, and cost-effectiveness associated with the provision of both types of services.
ClinicalTrials.gov: NCT01848080.
Université de Sherbrooke, Sherbrooke, QC, Canada. michel.tousignant@usherbrooke.ca.
Michel
M
Tousignant
Hélène
H
Corriveau
Dahlia
D
Kairy
Katherine
K
Berg
Marie-France
MF
Dubois
Sylvie
S
Gosselin
Richard H
RH
Swartz
Jean-Martin
JM
Boulanger
Cynthia
C
Danells
D002170:Canada; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000191:economics; D017048:Health Care Costs; D018575:Home Care Services, Hospital-Based / Q000191:economics; D006792:House Calls / Q000191:economics; D006801:Humans; D009043:Motor Activity; D017060:Patient Satisfaction; D004856:Postural Balance; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D020521:Stroke / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D026302:Tai Ji / Q000191:economics; D017216:Telemedicine / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome