NCT04787315

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 5, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

3.3 years

First QC Date

March 2, 2021

Last Update Submit

June 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    In the third or fourth week of rehabilitation

Secondary Outcomes (6)

  • Gait speed

    Baseline, pre-intensive rehabilitation

  • Balance capacities

    Baseline, pre-intensive rehabilitation

  • Gross manual dexterity

    Baseline, pre-intensive rehabilitation

  • Gait speed

    End-measure, at the end of rehabilitation

  • Balance capacities

    End-measure, at the end of rehabilitation

  • +1 more secondary outcomes

Study Arms (2)

Intensive rehabilitation without workstation

ACTIVE COMPARATOR
Behavioral: Conventional intensive functional rehabilitation

Intensive rehabilitation with workstations

EXPERIMENTAL
Device: Conventional intensive functional rehabilitation + Workstations

Interventions

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

Intensive rehabilitation with workstations

Includes rehabilitation interventions provided by professionnals (OT, PT, speech language therapy, neuropsychologists...)

Intensive rehabilitation without workstation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cognitive deficits preventing participation to rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS centre-sud-de-l'ile-de-Montréal

Montreal, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cyril Duclos, PhD

    CIUSSS Centre-Sud-de-l'ile-de-Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 8, 2021

Study Start

October 5, 2019

Primary Completion

January 31, 2023

Study Completion

September 30, 2023

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations