Clinical trial NCT06327035: Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Gait, Hemiplegic
Keywords: stroke
lower limb
gait recovery
balance
Lead sponsor: Clinique Les Trois Soleils
Sponsor class: OTHER
Collaborators: name: Le Normandy
First posted: 2024-03-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patient hospitalized in one of the investigating centers during acute/subacute phase.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional Ambulation Classification
timeFrame: 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 outcomes:
measure: Postural Assesment Scale for Stroke Patient
timeFrame: 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).
measure: Timed Up and Go
timeFrame: 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).
measure: 10-Meter Walk Test
timeFrame: 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).
measure: 6Minute-Walk Test
timeFrame: 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).
measure: Motricity Index
timeFrame: 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).
Other outcomes:
Locations:
city: Granville
country: France
facility: Le Normandy
state: Normandie
city: Boissise-le-Roi
country: France
facility: Clinique Les Trois Soleils
city: Boissise-le-Roi
country: France
facility: La Clinique Les Trois Soleils
Study officials:
affiliation: Les Trois Soleils
name: Christophe T Duret, MD
role: PRINCIPAL_INVESTIGATOR
References: