- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327035
Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center (PROWALK)
Neurological Recovery of the Paretic Lower Limb and Balance and Walking Abilities in the Subacute Phase of Stroke in Patients Hospitalized in Medical and Rehabilitation Units: A Prospective Multicenter Longitudinal Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anne-Gaëlle Grosmaire
- Phone Number: +33164717372
- Email: ag.grosmaire@les-trois-soleils.fr
Study Contact Backup
- Name: Ophélie Pila, Phd
- Email: o.pila@les-trois-soleils.fr
Study Locations
-
-
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Boissise-le-Roi, France, 77310
- Recruiting
- Clinique Les Trois Soleils
-
Contact:
- Christophe Duret, MD
- Email: ch.duret@les-trois-soleils.fr
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Principal Investigator:
- Christophe Duret, MD
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Boissise-le-Roi, France, 77310
- Recruiting
- La Clinique Les Trois Soleils
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Principal Investigator:
- Christophe Duret, MD
-
Contact:
- Ophélie Pila, PhD
-
Sub-Investigator:
- Anne Peskine, MD
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Normandy
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Granville, Normandy, France, 50400
- Recruiting
- Le Normandy
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Contact:
- Anne Peskine, MD
- Phone Number: +33233903333
- Email: apeskine.normandy@lna-sante.com
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Contact:
- Soizic Injeyan, PT
- Phone Number: +33233903333
- Email: dirmissions.normandy@lna-sante.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient hospitalized in one of the investigating centers after acute/subacute stroke.
- Affiliated to a social security scheme
Exclusion Criteria:
- Opposed to its participation in this study
- Neurodegenerative disease impacting gait prior to stroke onset
- Patient not walking before stroke
- Progressive pathology with life-threatening consequences within 6 months
- Patient under legal protection
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Ambulation Classification
Time Frame: Functional Ambulation Classification will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability.
|
Functional Ambulation Classification will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Assesment Scale for Stroke Patient
Time Frame: Postural Assesment Scale for Stroke Patient will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
The Postural Assessment Scale for Stroke Patients (PASS) assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance. The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36, the higher the score is, the more favourable the balance in stroke patients. |
Postural Assesment Scale for Stroke Patient will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
|
Timed Up and Go
Time Frame: Timed Up and Go will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
The Timed Up and Go is a general physical performance test used to assess mobility, balance and locomotor performance.
More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning.
|
Timed Up and Go will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
|
10-Meter Walk Test
Time Frame: 10-Meter Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
|
10-Meter Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
|
6Minute-Walk Test
Time Frame: 6Minute-Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
|
6Minute-Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
|
Motricity Index
Time Frame: Motricity Index will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
The Motricity Index (MI) is an ordinal method of measuring limb strength.
The total score ranges from 0 - 100, with the higher numbers representing good muscle strength.
|
Motricity Index will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christophe T Duret, MD, Les Trois Soleils
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A02660-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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