Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center

NCT06327035 | Recruiting

• 1 other identifier: 2023-A02660-45
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke; Gait, Hemiplegic

Keywords

stroke; lower limb; gait recovery; balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

• 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).

Interventions

Gait rehabilitation OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patient hospitalized in one of the investigating centers during acute/subacute phase.

You may qualify if:

• Patient hospitalized in one of the investigating centers after acute/subacute stroke.
• Affiliated to a social security scheme

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Les Trois Soleils: lead
• Le Normandy: collaborator

Study Sites (3)

Le Normandy

Granville, Normandy, 50400, France

RECRUITING

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

RECRUITING

La Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

RECRUITING

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christophe T Duret, MD

  Les Trois Soleils

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Gaëlle Grosmaire

CONTACT

+33164717372; ag.grosmaire@les-trois-soleils.fr

Ophélie Pila, Phd

CONTACT

o.pila@les-trois-soleils.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 25, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

FR (3)