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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06327035
Other study ID # 2023-A02660-45
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 26, 2024
Est. completion date April 1, 2025

Study information

Verified date March 2024
Source Clinique Les Trois Soleils
Contact Anne-Gaëlle Grosmaire
Phone +33164717372
Email ag.grosmaire@les-trois-soleils.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Gait rehabilitation
Assessment of gait and balance abilities after stroke during neurorehabilitation from the subacute phase of stroke to 6 months after stroke. The assessments will be carried out on entrance to the neurological center, then at 1 ,3 and 6 months and on hospital discharge.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Clinique Les Trois Soleils Le Normandy

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Ambulation Classification 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 Postural Assesment Scale for Stroke Patient 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).
Secondary Timed Up and Go 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).
Secondary 10-Meter Walk Test 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).
Secondary 6Minute-Walk Test 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).
Secondary Motricity Index 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).
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