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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848080
• Other study ID #: 10-217-S1
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 16, 2021

Study information

• Verified date: September 2021
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 16, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Tai 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.

Locations

Country	Name	City	State
Canada	Hôpital Charles-LeMoyne	Longueuil
Canada	Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain	Montréal
Canada	Research Centre on Aging	Sherbrooke

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Université de Montréal, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mobility at 2 and 4 months	Community balance and mobility Scale.	before the intervention, month 2 and month 4
Primary	Change from baseline in Balance at 2 and 4 months	Community balance and mobility Scale.	before the intervention, month 2 and month 4
Secondary	Change from baseline walking speed at 2 and 4 months	Speed: Timed up and go (TUG),	before the intervention, month 2, month 4
Secondary	Change from baseline Psychological Attitudes related to balance at 2 and 4 months	Self efficacy: General Perceived Self efficacy	before the intervention, month 2, month 4
Secondary	Change from baseline Quality of life at 2 and 4 month	Quality of life: Reintegration ti normal Living Index (RNLI)	before the intervention, month 2, month 4
Secondary	Change from Baseline Satisfaction with the care received at 2 and 4 months	Satisfaction with the care received = Health care satisfaction questionnaire	before the intervention, month 2, month 4
Secondary	Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months	Cost of services from the perspective of the health system = "Cost-analysis of telemedicine" from the Minnesota University	before the intervention, month 2, month 4
Secondary	Change from baseline walking endurance at 2 and 4 months	distance in meters walked two minutes	before the intervention, month 2 and month 4
Secondary	Change from baseline aptitude for Balance at 2 and 4 months	Four-Squares Test	before the intervention, month 2 and month 4
Secondary	Change from baseline Strength of lower limbs at 2 and 4 months	Sit to Stand Test	before the intervention, month 2 and month 4
Secondary	Change from baseline Psychological Attitudes related to mobility at 2 and 4 months	fear of falling: Activities-specific Balance confidence scale	before the intervention, month 2, month 4

External Links

•   Complete and published research protocol