- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04787315
Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation
June 7, 2022 updated by: Cyril Duclos, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation Using an Activity Circuit Implemented With a Change Agent
The project aims to implement workstations for mobility training during intensive inpatient rehabilitation to increase the level of motor activity of individuals with hemiparesis due to stroke
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cyril Duclos, PhD
- Phone Number: 26381 514 343 6111
- Email: cyril.duclos@umontreal.ca
Study Contact Backup
- Name: Claire Croteau, PhD
- Phone Number: 514 343 7007
- Email: claire.croteau@umontreal.ca
Study Locations
-
-
-
Montréal, Canada
- Recruiting
- CIUSSS centre-sud-de-l'ile-de-Montréal
-
Contact:
- Myriam Vezina, MSc
- Email: myriam.vezina.ccsmtl@ssss.gouv.qc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (IRGLM)
Exclusion Criteria:
- Cognitive deficits preventing participation to rehabilitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intensive rehabilitation without workstation
|
Includes rehabilitation interventions provided by professionnals (OT, PT, speech language therapy, neuropsychologists...)
|
Experimental: Intensive rehabilitation with workstations
|
Equipment will be provided to participants where they can do exercises to increase their motor abilities at the lower limbs, trunk and upper limbs, in addition to conventional intensive functional rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actimetry
Time Frame: In the third or fourth week of rehabilitation
|
Measure of acceleration data of the paretic lower and upper-limbs by means of an accelerometer (actigraph (r)) placed at the ankle and wrist during seven consecutive days
|
In the third or fourth week of rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait speed
Time Frame: Baseline, pre-intensive rehabilitation
|
Measured using the 10-meter walking speed test
|
Baseline, pre-intensive rehabilitation
|
Balance capacities
Time Frame: Baseline, pre-intensive rehabilitation
|
Measured using the MiniBESTest or Berg Balance scale according to abilities
|
Baseline, pre-intensive rehabilitation
|
Gross manual dexterity
Time Frame: Baseline, pre-intensive rehabilitation
|
Measured using the Box and Block test
|
Baseline, pre-intensive rehabilitation
|
Gait speed
Time Frame: End-measure, at the end of rehabilitation
|
Measured using the 10-meter walking speed test
|
End-measure, at the end of rehabilitation
|
Balance capacities
Time Frame: End-measure, at the end of rehabilitation
|
Measured using the MiniBESTest or Berg Balance scale according to abilities
|
End-measure, at the end of rehabilitation
|
Gross manual dexterity
Time Frame: End-measure, at the end of rehabilitation
|
Measured using the Box and Block test
|
End-measure, at the end of rehabilitation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cyril Duclos, PhD, CIUSSS centre-sud-de-l'ile-de-Montréal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2019
Primary Completion (Anticipated)
January 31, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
March 2, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRIR-1423-0719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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