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

Stroke Clinical Trial

— PROWALK  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327035
• Other study ID #: 2023-A02660-45
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke

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).