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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03009773
Other study ID # PI2016_843_0007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2017
Est. completion date May 10, 2024

Study information

Verified date September 2022
Source Centre Hospitalier Universitaire, Amiens
Contact Sophie TASSEEL-PONCHE, Doctor
Phone +33 322 455 735
Email tasseel-ponche.sophie@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke is the leading cause of severe disability in adults. The first cause of alterations in the quality of life and autonomy in these patients are disorders of walking and the balance. They are the leading cause of falls responsible for important medical, surgical and economic complications as well as a reactionary social isolation. The techniques of rehabilitation of walking to the subacute phase of a stroke are usually based on automatic walking.Off walking is a complex activity usually performed in everyday life in association with multiple tasks. It is therefore interesting to re-educate walking in dual task or even in multitasking.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 10, 2024
Est. primary completion date May 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Major: age between 18 and 90 years - Hospitalized for ischemic or hemorrhagic hemispheric stroke confirmed by CT or MRI <6months - walking disorder with the possibility of walking 10 meters with or without technical assistance (speed <1.2m / s) - verbal understanding with complex orders - Affiliates to social security Exclusion Criteria: - Brainstem stroke or cerebellar - Hypoacusia annoying understanding - Visual gene embarrassing awarding - severe aphasia: no understanding of complex orders - neurological or musculoskeletal history affecting walking - Participation in interventional research protocol in motor rehabilitation of the lower limb or cognitive - Patient under guardianship or deprived of liberty - pregnant women, parturient women or lactating (art L.1121-5)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
rehabilitation multitasking walking.
rehabilitation multitasking walking.
Traditional walking rehabilitation
Traditional walking rehabilitation

Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (12)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens CENTRE DE REEDUCATION FONCTIONNELLE L'ESPOIR LILLE, CENTRE DE REEDUCATION FONCTIONNELLE SAINT-LAZARE, Centre Hospitalier Arras, Centre Régional de Médecine Physique et de Réadaptation - Les herbiers, CH COMPIEGNE, CH CORBIE, CH Le Havre, Clinique de rééducation fonctionnelle Le Belloy, Fondation Hopale, Institut Médical de Breteuil, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure walking speed Speed of the simple task of walking 10 meters testing. 6 months
Secondary Description of different types of walking disorders and balance in the subacute phase of stroke Currently no clinical scale exists in the literature at our knowledge. The walk of the patients will be qualitatively analyzed by the investigator in order to measure the prevalence of the different clinical categories of walking disorders according to their semiological characteristics inclusion
Secondary Score neuromotor the lower limb Score neuromotor the lower limb: Fugl Meyer 6 months
Secondary Dynamic equilibrium to TUG single and double cognitive task Dynamic equilibrium to TUG single and double cognitive task 6 months
Secondary Walking speed double cognitive task Walking speed double cognitive task 6 months
Secondary Executive functions: a battery of neuropsychological Executive functions: a battery of neuropsychological 6 months
Secondary Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT 6 months
Secondary EVA Quality of life EVA (Visual Analogic Scale) quality of life 6 months
Secondary Correlation of cognitive gains with the gain of the walking speed of 10 meters Correlation of cognitive gains with the gain of the walking speed of 10 meters 6 months
Secondary anatomoclinical correlations Lesion score of gray matter and white matter (Volumetry on sequences 3DT1 and Flair) Cerebral 6 months
See also
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Active, not recruiting NCT01383512 - Rehabilitation Robotics After a Stroke N/A
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Withdrawn NCT01939041 - Efficacy of Unilateral Versus Bilateral Approach to Robot-Assisted Rehabilitation in Patients With Subacute Stroke N/A
Not yet recruiting NCT06210516 - Respiratory Muscle Training in Patients With Subacute Ischemic Stroke N/A