NCT03009773

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

October 14, 2022

Status Verified

September 1, 2022

Enrollment Period

6.1 years

First QC Date

November 14, 2016

Last Update Submit

October 12, 2022

Conditions

Keywords

subacute strokemultitasking rehabilitationwalking

Outcome Measures

Primary Outcomes (1)

  • Measure walking speed

    Speed of the simple task of walking 10 meters testing.

    6 months

Secondary Outcomes (9)

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

    inclusion

  • Score neuromotor the lower limb

    6 months

  • Dynamic equilibrium to TUG single and double cognitive task

    6 months

  • Walking speed double cognitive task

    6 months

  • Executive functions: a battery of neuropsychological

    6 months

  • +4 more secondary outcomes

Study Arms (2)

multitasking walking

EXPERIMENTAL

Multitasking Group: rehabilitation multitasking walking.

Other: rehabilitation multitasking walking.

walking simple task

ACTIVE COMPARATOR

Simple task group : Traditional walking rehabilitation

Other: Traditional walking rehabilitation

Interventions

rehabilitation multitasking walking.

multitasking walking

Traditional walking rehabilitation

walking simple task

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

Related Publications (1)

  • Tasseel-Ponche S, Roussel M, Toba MN, Sader T, Barbier V, Delafontaine A, Meynier J, Picard C, Constans JM, Schnitzler A, Godefroy O, Yelnik AP. Dual-task versus single-task gait rehabilitation after stroke: the protocol of the cognitive-motor synergy multicenter, randomized, controlled superiority trial (SYNCOMOT). Trials. 2023 Mar 8;24(1):172. doi: 10.1186/s13063-023-07138-x.

Study Officials

  • Sophie TASSEEL-PONCHE, Doctor

    CHU Amiens-Picardie France

    STUDY DIRECTOR
  • Eric VERIN, professor

    University Hospital, 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie TASSEEL-PONCHE, Doctor

CONTACT

Mohamed AIT AMER MEZIANE, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

January 4, 2017

Study Start

April 11, 2017

Primary Completion

May 10, 2023

Study Completion

May 10, 2024

Last Updated

October 14, 2022

Record last verified: 2022-09

Locations