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

Primary Purpose

Subacute Stroke

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

rehabilitation multitasking walking.

Traditional walking rehabilitation

About this trial

This is an interventional treatment trial for Subacute Stroke focused on measuring subacute stroke, multitasking rehabilitation, walking

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

multitasking walking

walking simple task

Arm Description

Multitasking Group: rehabilitation multitasking walking.

Simple task group : Traditional walking rehabilitation

Outcomes

Primary Outcome Measures

Measure walking speed

Speed of the simple task of walking 10 meters testing.

Secondary Outcome Measures

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

Score neuromotor the lower limb

Score neuromotor the lower limb: Fugl Meyer

Dynamic equilibrium to TUG single and double cognitive task

Walking speed double cognitive task

Executive functions: a battery of neuropsychological

Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT

EVA Quality of life

EVA (Visual Analogic Scale) quality of life

Correlation of cognitive gains with the gain of the walking speed of 10 meters

anatomoclinical correlations

Lesion score of gray matter and white matter (Volumetry on sequences 3DT1 and Flair) Cerebral

Full Information

NCT ID

NCT03009773

First Posted

November 14, 2016

Last Updated

October 12, 2022

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03009773

Brief Title

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

Acronym

SYNCOMOT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2017 (Actual)

Primary Completion Date

May 10, 2023 (Anticipated)

Study Completion Date

May 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subacute Stroke

Keywords

subacute stroke, multitasking rehabilitation, walking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

multitasking walking

Arm Type

Experimental

Arm Description

Multitasking Group: rehabilitation multitasking walking.

Arm Title

walking simple task

Arm Type

Active Comparator

Arm Description

Simple task group : Traditional walking rehabilitation

Intervention Type

Other

Intervention Name(s)

rehabilitation multitasking walking.

Intervention Description

rehabilitation multitasking walking.

Intervention Type

Other

Intervention Name(s)

Traditional walking rehabilitation

Intervention Description

Traditional walking rehabilitation

Primary Outcome Measure Information:

Title

Measure walking speed

Description

Speed of the simple task of walking 10 meters testing.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Description of different types of walking disorders and balance in the subacute phase of stroke

Description

Time Frame

inclusion

Title

Score neuromotor the lower limb

Description

Score neuromotor the lower limb: Fugl Meyer

Time Frame

6 months

Title

Dynamic equilibrium to TUG single and double cognitive task

Description

Dynamic equilibrium to TUG single and double cognitive task

Time Frame

6 months

Title

Walking speed double cognitive task

Description

Walking speed double cognitive task

Time Frame

6 months

Title

Executive functions: a battery of neuropsychological

Description

Executive functions: a battery of neuropsychological

Time Frame

6 months

Title

Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT

Description

Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT

Time Frame

6 months

Title

EVA Quality of life

Description

EVA (Visual Analogic Scale) quality of life

Time Frame

6 months

Title

Correlation of cognitive gains with the gain of the walking speed of 10 meters

Description

Correlation of cognitive gains with the gain of the walking speed of 10 meters

Time Frame

6 months

Title

anatomoclinical correlations

Description

Lesion score of gray matter and white matter (Volumetry on sequences 3DT1 and Flair) Cerebral

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie TASSEEL-PONCHE, Doctor

Phone

+33 322 455 735

tasseel-ponche.sophie@chu-amiens.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed AIT AMER MEZIANE, PHD

Phone

+ 33 322 088 384

aitamermeziane.mohamed@chu-amiens.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophie TASSEEL-PONCHE, Doctor

Organizational Affiliation

CHU Amiens-Picardie France

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eric VERIN, professor

Organizational Affiliation

CHU de Rouen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Etienne ALLART, Doctor

Organizational Affiliation

CHRU de Lille

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

DEMAILLE Samantha, professor

Organizational Affiliation

CRF 4Espoir Lille

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Valérie LECLERCQ-DONTGEZ, Doctor

Organizational Affiliation

Les 3 vallées

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Haykal ELLEUCH, Doctor

Organizational Affiliation

CH Arras

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marie DECOCQ-DEMICHEL, Doctor

Organizational Affiliation

CH Le Belloy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pascal RIGAUX, Doctor

Organizational Affiliation

CH Berck Sur Mer

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sabine POL-ROUX, Doctor

Organizational Affiliation

CH Compiègne

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sofiane LARIBI, Doctor

Organizational Affiliation

CH Breteuil

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Skander MOALLA, Doctor

Organizational Affiliation

Centre Hospitalier de Beauvais

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens Picardie

City

Amiens

State/Province

Picardie

ZIP/Postal Code

80054

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie TASSEEL-PONCHE, Dr

Phone

+33322455735

tasseel-ponche.sophie@chu-amiens.fr

12. IPD Sharing Statement

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

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