NCT01848080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

8.1 years

First QC Date

April 26, 2013

Last Update Submit

September 27, 2021

Conditions

Stroke

Keywords

TelemedicineTelerehabilitationAcute StrokeTai ChiTai JiRehabilitationHome care servicesSingle blind methodRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in mobility at 2 and 4 months

    Community balance and mobility Scale.

    before the intervention, month 2 and month 4

  • Change from baseline in Balance at 2 and 4 months

    Community balance and mobility Scale.

    before the intervention, month 2 and month 4

Secondary Outcomes (9)

  • Change from baseline walking speed at 2 and 4 months

    before the intervention, month 2, month 4

  • Change from baseline Psychological Attitudes related to balance at 2 and 4 months

    before the intervention, month 2, month 4

  • Change from baseline Quality of life at 2 and 4 month

    before the intervention, month 2, month 4

  • Change from Baseline Satisfaction with the care received at 2 and 4 months

    before the intervention, month 2, month 4

  • Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months

    before the intervention, month 2, month 4

  • +4 more secondary outcomes

Study Arms (2)

Tai chi program via Telerehabilitation

EXPERIMENTAL

An 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.

Behavioral: Tai Chi based exercise program

Tai chi program via home visits

ACTIVE COMPARATOR

An 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.

Behavioral: Tai Chi based exercise program

Interventions

Tai Chi based exercise programBEHAVIORAL

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.

Tai chi program via TelerehabilitationTai chi program via home visits

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • severe body hemineglect;
  • significant hemianopsia visual problems accompanied by hemineglect;
  • uncontrolled medical problems;
  • moderate to severe aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Charles-LeMoyne

Longueuil, Canada

Location

Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain

Montreal, Canada

Location

Research Centre on Aging

Sherbrooke, Canada

Location

Related 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.

    PMID: 24479760BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michel Tousignant, PhD

    Research Centre on Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PH.D.

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 7, 2013

Study Start

June 1, 2013

Primary Completion

July 14, 2021

Study Completion

September 16, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

CA(3)