Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation

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

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

Study Contact Backup

Study Locations

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

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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