The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)? (SYNCOMOT)

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.

Study Overview

• Status: Recruiting
• Conditions: Subacute Stroke
• Intervention / Treatment: Other: rehabilitation multitasking walking.; Other: Traditional walking rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie TASSEEL-PONCHE, Doctor; Phone Number: +33 322 455 735; Email: tasseel-ponche.sophie@chu-amiens.fr
• Study Contact Backup: Name: Mohamed AIT AMER MEZIANE, PHD; Phone Number: + 33 322 088 384; Email: aitamermeziane.mohamed@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Sophie TASSEEL-PONCHE, Dr; Phone Number: +33322455735; Email: tasseel-ponche.sophie@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multitasking walking; Multitasking Group: rehabilitation multitasking walking.	Other: rehabilitation multitasking walking.; rehabilitation multitasking walking.
Active Comparator: walking simple task; Simple task group : Traditional walking rehabilitation	Other: Traditional walking rehabilitation; Traditional walking rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure walking speed	Speed of the simple task of walking 10 meters testing.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Score neuromotor the lower limb	Score neuromotor the lower limb: Fugl Meyer	6 months
Dynamic equilibrium to TUG single and double cognitive task	Dynamic equilibrium to TUG single and double cognitive task	6 months
Walking speed double cognitive task	Walking speed double cognitive task	6 months
Executive functions: a battery of neuropsychological	Executive functions: a battery of neuropsychological	6 months
Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT	Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT	6 months
EVA Quality of life	EVA (Visual Analogic Scale) quality of life	6 months
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
anatomoclinical correlations	Lesion score of gray matter and white matter (Volumetry on sequences 3DT1 and Flair) Cerebral	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Lille; Centre Hospitalier Arras; CH Le Havre; CH Compiègne; CENTRE DE REEDUCATION FONCTIONNELLE L'ESPOIR LILLE; CENTRE DE REEDUCATION FONCTIONNELLE SAINT-LAZARE; Centre Régional de Médecine Physique et de Réadaptation - Les herbiers; CH CORBIE; Clinique de rééducation fonctionnelle Le Belloy; Fondation Hopale; Institut Médical de Breteuil
• Investigators: Study Director: Sophie TASSEEL-PONCHE, Doctor, CHU Amiens-Picardie France; Principal Investigator: Eric VERIN, professor, CHU de Rouen; Principal Investigator: Etienne ALLART, Doctor, Chru De Lille; Principal Investigator: DEMAILLE Samantha, professor, CRF 4Espoir Lille; Principal Investigator: Valérie LECLERCQ-DONTGEZ, Doctor, Les 3 vallées; Principal Investigator: Haykal ELLEUCH, Doctor, CH ARRAS; Principal Investigator: Marie DECOCQ-DEMICHEL, Doctor, CH Le Belloy; Principal Investigator: Pascal RIGAUX, Doctor, CH Berck Sur Mer; Principal Investigator: Sabine POL-ROUX, Doctor, CH Compiègne; Principal Investigator: Sofiane LARIBI, Doctor, CH Breteuil; Principal Investigator: Skander MOALLA, Doctor, Centre Hospitalier de Beauvais

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Anticipated): May 10, 2023
• Study Completion (Anticipated): May 10, 2024

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: January 2, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: walking; subacute stroke; multitasking rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PI2016_843_0007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No