Stroke Clinical Trial
— PROWALKOfficial title:
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
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Clinique Les Trois Soleils | Le Normandy |
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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