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Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Conventional intensive functional rehabilitation + Workstations
Conventional intensive functional rehabilitation
Sponsored by
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (IRGLM)

Exclusion Criteria:

  • Cognitive deficits preventing participation to rehabilitation

Sites / Locations

  • CIUSSS centre-sud-de-l'ile-de-MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intensive rehabilitation without workstation

Intensive rehabilitation with workstations

Arm Description

Outcomes

Primary Outcome Measures

Actimetry
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

Secondary Outcome Measures

Gait speed
Measured using the 10-meter walking speed test
Balance capacities
Measured using the MiniBESTest or Berg Balance scale according to abilities
Gross manual dexterity
Measured using the Box and Block test
Gait speed
Measured using the 10-meter walking speed test
Balance capacities
Measured using the MiniBESTest or Berg Balance scale according to abilities
Gross manual dexterity
Measured using the Box and Block test

Full Information

First Posted
March 2, 2021
Last Updated
June 7, 2022
Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT04787315
Brief Title
Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation
Official Title
Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation Using an Activity Circuit Implemented With a Change Agent
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2019 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive rehabilitation without workstation
Arm Type
Active Comparator
Arm Title
Intensive rehabilitation with workstations
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Conventional intensive functional rehabilitation + Workstations
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional intensive functional rehabilitation
Intervention Description
Includes rehabilitation interventions provided by professionnals (OT, PT, speech language therapy, neuropsychologists...)
Primary Outcome Measure Information:
Title
Actimetry
Description
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
Time Frame
In the third or fourth week of rehabilitation
Secondary Outcome Measure Information:
Title
Gait speed
Description
Measured using the 10-meter walking speed test
Time Frame
Baseline, pre-intensive rehabilitation
Title
Balance capacities
Description
Measured using the MiniBESTest or Berg Balance scale according to abilities
Time Frame
Baseline, pre-intensive rehabilitation
Title
Gross manual dexterity
Description
Measured using the Box and Block test
Time Frame
Baseline, pre-intensive rehabilitation
Title
Gait speed
Description
Measured using the 10-meter walking speed test
Time Frame
End-measure, at the end of rehabilitation
Title
Balance capacities
Description
Measured using the MiniBESTest or Berg Balance scale according to abilities
Time Frame
End-measure, at the end of rehabilitation
Title
Gross manual dexterity
Description
Measured using the Box and Block test
Time Frame
End-measure, at the end of rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (IRGLM) Exclusion Criteria: Cognitive deficits preventing participation to rehabilitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyril Duclos, PhD
Phone
514 343 6111
Ext
26381
Email
cyril.duclos@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Croteau, PhD
Phone
514 343 7007
Email
claire.croteau@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril Duclos, PhD
Organizational Affiliation
CIUSSS Centre-Sud-de-l'ile-de-Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS centre-sud-de-l'ile-de-Montréal
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Vezina, MSc
Email
myriam.vezina.ccsmtl@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation

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