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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Unknown status
CT.gov ID
NCT03009773
Collaborator
(none)
300
1
2
30
10

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: rehabilitation multitasking walking.
  • Other: Traditional walking rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)?
Actual Study Start Date :
Apr 11, 2017
Anticipated Primary Completion Date :
Oct 11, 2019
Anticipated Study Completion Date :
Oct 11, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Measure walking speed [6 months]

    Speed of the simple task of walking 10 meters testing.

Secondary Outcome Measures

  1. Description of different types of walking disorders and balance in the subacute phase of stroke [inclusion]

    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

  2. Score neuromotor the lower limb [6 months]

    Score neuromotor the lower limb: Fugl Meyer

  3. Dynamic equilibrium to TUG single and double cognitive task [6 months]

    Dynamic equilibrium to TUG single and double cognitive task

  4. Walking speed double cognitive task [6 months]

    Walking speed double cognitive task

  5. Executive functions: a battery of neuropsychological [6 months]

    Executive functions: a battery of neuropsychological

  6. Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT [6 months]

    Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT

  7. EVA Quality of life [6 months]

    EVA (Visual Analogic Scale) quality of life

  8. Correlation of cognitive gains with the gain of the walking speed of 10 meters [6 months]

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

  9. anatomoclinical correlations [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens Picardie France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT03009773
Other Study ID Numbers:
  • PI2016_843_0007
First Posted:
Jan 4, 2017
Last Update Posted:
Sep 13, 2018
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2018