NCT03559283

Brief Summary

This study evaluates cognitive-motor interference in stroke patients who is responsible an alteration of spatio-temporal gait parameters. It's proved in the literature but the underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional imaging technique that evaluates this interference under optimal conditions. The purpose of this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients under different DT conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

March 27, 2026

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

June 6, 2018

Last Update Submit

March 24, 2026

Conditions

Keywords

stroke, dual-task, gait parameters, fNIRS

Outcome Measures

Primary Outcomes (1)

  • Cost of the Double Task

    the double task (DT) cost measured by the average difference in magnitude of hemodynamic responses in HbO2 at the CPF level obtained by the fNIRS between the DT high and low cognitive load.

    Day of the Inclusion

Secondary Outcomes (2)

  • Impact of the double task on spatio-temporal parameters of walking and on cognition

    Day of the Inclusion

  • Evaluate the asymmetry of cerebral activation in different walking conditions

    Day of the Inclusion

Study Arms (1)

Walking and Record Cortical Activity

EXPERIMENTAL

A sensor placement will be performed on the patient's forehead to record brain activity when walking, when performing a mental task, and when performing both tasks at the same time. In parallel, walking will be on a carpet that will record the spatio-temporal parameters of walking.

Diagnostic Test: Walking and Record Cortical Activity

Interventions

The cortical activity of each patient is recorded by NIRS under the following conditions: * Simple task : The patient walks on an electronic walking track (GAITRite system) over 10 meters. The data collected are the spatio-temporal parameters of walking. * Cognitive task alone : two conditions of the n-back test (1-back and 2-back) to study neural activities related to working memory. The duration of realization will be 30 seconds by condition and we retain the number of errors realized. * Double Task : Achievement of the motor task (10-meter walk) is performed at the same time as a "weak" cognitive task (1-back) and a "high" cognitive task (2-back). The spatio-temporal parameters and the number of errors are collected by the observer.

Walking and Record Cortical Activity

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient between 55 and 75 years old
  • First stroke
  • ischemic sylvian or hemorrhagic lobar deep respecting the frontal lobe, subacute phase (J15-J90),
  • patient walking 10 meters.

You may not qualify if:

  • Heminegligencia,
  • a history of neurological pathologies, orthopedic pathologies, aphasia, cognitive disorders preceding stroke (dementia, head trauma), acute cardiovascular or respiratory pathologies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Limoges, 87042, France

Location

Related Publications (1)

  • Hermand E, Tapie B, Dupuy O, Fraser S, Compagnat M, Salle JY, Daviet JC, Perrochon A. Prefrontal Cortex Activation During Dual Task With Increasing Cognitive Load in Subacute Stroke Patients: A Pilot Study. Front Aging Neurosci. 2019 Jul 2;11:160. doi: 10.3389/fnagi.2019.00160. eCollection 2019.

MeSH Terms

Conditions

Stroke

Interventions

Walking

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

November 26, 2018

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

March 27, 2026

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations