StrokeNCT04787315
Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation
A study testing Conventional intensive functional rehabilitation + Workstations and Conventional intensive functional rehabilitation in people with Stroke, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional intensive functional rehabilitation + Workstations and Conventional intensive functional rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (IRGLM)
Who cannot join
- Cognitive deficits preventing participation to rehabilitation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS centre-sud-de-l'ile-de-Montréal
Montreal
Myriam Vezina, MSc, myriam.vezina.ccsmtl@ssss.gouv.qc.ca
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- Conventional intensive functional rehabilitation + Workstations, Conventional intensive functional rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional intensive functional rehabilitation + WorkstationsDevice
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
Conventional intensive functional rehabilitationBehavioural
Includes rehabilitation interventions provided by professionnals (OT, PT, speech language therapy, neuropsychologists...)
| Study group | Role | What they receive |
|---|---|---|
| Intensive rehabilitation without workstation | Active comparator | Not described Receives: Behavioral: Conventional intensive functional rehabilitation |
| Intensive rehabilitation with workstations | Experimental | Not described Receives: Device: Conventional intensive functional rehabilitation + Workstations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In the third or fourth week of rehabilitation
Secondary outcomes (6)
Gait speed
Measured using the 10-meter walking speed test
Measured: Baseline, pre-intensive rehabilitation
Balance capacities
Measured using the MiniBESTest or Berg Balance scale according to abilities
Measured: Baseline, pre-intensive rehabilitation
Gross manual dexterity
Measured using the Box and Block test
Measured: Baseline, pre-intensive rehabilitation
Gait speed
Measured using the 10-meter walking speed test
Measured: End-measure, at the end of rehabilitation
Balance capacities
Measured using the MiniBESTest or Berg Balance scale according to abilities
Measured: End-measure, at the end of rehabilitation
Gross manual dexterity
Measured using the Box and Block test
Measured: End-measure, at the end of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start5 Oct 2019
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cyril Duclos, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Investigators
- Cyril Duclos, PhD, Principal investigator, CIUSSS Centre-Sud-de-l'ile-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787315
- Sponsor's protocol ID
- CRIR-1423-0719
- Status last verified
- Jun 2022
- First submitted
- 2 Mar 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation Using an Activity Circuit Implemented With a Change Agent
- ClinicalTrials.gov ID
- NCT04787315
- Acronym / sponsor ID
- CRIR-1423-0719
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive rehabilitation without workstation | Active comparator | Behavioral: Conventional intensive functional rehabilitation |
| Intensive rehabilitation with workstations | Experimental | Device: Conventional intensive functional rehabilitation + Workstations |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (IRGLM)
Key exclusion criteria (1 listed)
- Cognitive deficits preventing participation to rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional intensive functional rehabilitation + WorkstationsEquipment 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 | Device | Intensive rehabilitation with workstations |
| Conventional intensive functional rehabilitationIncludes rehabilitation interventions provided by professionnals (OT, PT, speech language therapy, neuropsychologists...) | Behavioural | Intensive rehabilitation without workstation |
Primary outcome
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
6 secondary outcomes
Gait speed
Time frame: Baseline, pre-intensive rehabilitation
Balance capacities
Time frame: Baseline, pre-intensive rehabilitation
Gross manual dexterity
Time frame: Baseline, pre-intensive rehabilitation
Gait speed
Time frame: End-measure, at the end of rehabilitation
Balance capacities
Time frame: End-measure, at the end of rehabilitation
Gross manual dexterity
Time frame: End-measure, at the end of rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril Duclos, PhD principal investigator
CIUSSS Centre-Sud-de-l'ile-de-Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional intensive functional rehabilitation + Workstations and Conventional intensive functional rehabilitation in people with Stroke, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cyril Duclos, PhD (514 343 6111 ext. 26381, cyril.duclos@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actimetry (time frame: In the third or fourth week of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.