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NCT Number: NCT06327035

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Le Normandy, Granville, Normandy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Postural Assesment Scale for Stroke Patient

    Time frame: 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).

    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.

  2. Timed Up and Go

    Time frame: 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).

    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.

  3. 10-Meter Walk Test

    Time frame: 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).

    The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance

  4. 6Minute-Walk Test

    Time frame: 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).

    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.

  5. Motricity Index

    Time frame: 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Gaëlle Grosmaire

CONTACT

[email protected]

+33164717372

Ophélie Pila, Phd

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Clinique Les Trois Soleils

Other

Collaborators

  • Le Normandy

Registry information

Official study 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

Acronym: PROWALK

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 25, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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