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Clinical Trials/NCT06327035
NCT06327035
Recruiting
Not Applicable

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

Clinique Les Trois Soleils3 sites in 1 country400 target enrollmentMarch 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Clinique Les Trois Soleils
Enrollment
400
Locations
3
Primary Endpoint
Functional Ambulation Classification
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2024
End Date
April 1, 2028
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinique Les Trois Soleils
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Motricity Index(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).)
  • Postural Assesment Scale for Stroke Patient(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(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(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(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).)

Study Sites (3)

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