NCT02664636

Brief Summary

The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

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

January 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

November 19, 2025

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

January 19, 2016

Last Update Submit

November 17, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (40)

  • Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Day 0

  • Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Day 15

  • Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Day 30

  • Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Day 45

  • Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Day 60

  • Near-infrared spectroscopy signal analysis: the amplitude peak

    Day 0

  • Near-infrared spectroscopy signal analysis: the amplitude peak

    Day 15

  • Near-infrared spectroscopy signal analysis: the amplitude peak

    Day 30

  • Near-infrared spectroscopy signal analysis: the amplitude peak

    Day 45

  • Near-infrared spectroscopy signal analysis: the amplitude peak

    Day 60

  • Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Day 0

  • Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Day 15

  • Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Day 30

  • Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Day 45

  • Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Day 60

  • Near-infrared spectroscopy signal analysis: the laterality index

    Day 0

  • Near-infrared spectroscopy signal analysis: the laterality index

    Day 15

  • Near-infrared spectroscopy signal analysis: the laterality index

    Day 30

  • Near-infrared spectroscopy signal analysis: the laterality index

    Day 45

  • Near-infrared spectroscopy signal analysis: the laterality index

    Day 60

  • Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Voluntary force refers to the force applied during motricity tasks.

    Day 0

  • Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Voluntary force refers to the force applied during motricity tasks.

    Day 15

  • Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Voluntary force refers to the force applied during motricity tasks.

    Day 30

  • Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Voluntary force refers to the force applied during motricity tasks.

    Day 45

  • Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Voluntary force refers to the force applied during motricity tasks.

    Day 60

  • Voluntary force: average

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

    Day 0

  • Voluntary force: average

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

    Day 15

  • Voluntary force: average

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

    Day 30

  • Voluntary force: average

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

    Day 45

  • Voluntary force: average

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

    Day 60

  • Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Day 0

  • Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Day 15

  • Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Day 30

  • Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Day 45

  • Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Day 60

  • Fugl-Meyer motricity score

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

    Day 0

  • Fugl-Meyer motricity score

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

    Day 15

  • Fugl-Meyer motricity score

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

    Day 30

  • Fugl-Meyer motricity score

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

    Day 45

  • Fugl-Meyer motricity score

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

    Day 60

Secondary Outcomes (6)

  • The Box and Block test: The score is the number of blocks transferred in one minute.

    Day 0

  • The Box and Block test: The score is the number of blocks transferred in one minute.

    Day 60

  • The Nine Hole Peg Test: The score is the total time to complete the task.

    Day 0

  • The Nine Hole Peg Test: The score is the total time to complete the task.

    Day 60

  • The Barthell test for autonomy

    Day 0

  • +1 more secondary outcomes

Study Arms (1)

The study population

EXPERIMENTAL

The study population consists of patients 20 and 75 years of age who have had a supra-tentorial ischemic or hemorrhagic stroke. The study covers consulting or hospitalized patients at the neurological rehabilitation service (NHS) of Grau du Roi Medical Center, part of the Nîmes University Hospital. Most patients originate from a 2-4 week stay in the neurological acute care, cardiac or polyvalent departments of the University Hospitals of Montpellier or Nîmes. Intervention: Physiotherapy Intervention: Occupational therapy Intervention: Functional near-infrared spectroscopy

Procedure: PhysiotherapyProcedure: Occupational therapyProcedure: Functional near-infrared spectroscopy

Interventions

PhysiotherapyPROCEDURE

Physiotherapy regimen (days 0 to 60): orthopedic maintenance, work on trunk balance, sensorimotor techniques for restoration of motor skills, exercises for standing balance and walking. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. They occur as daily sessions during the first two weeks and then two sessions / day. This is part of routine care.

The study population
Occupational therapyPROCEDURE

Occupational Therapy (days 0 to 60): Orthopaedic maintenance, exercises for sitting and standing balance, sensorimotor techniques for the restoration of motor skills, grip exercises. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. 1 session is performed per day. This is part of routine care.

The study population
Functional near-infrared spectroscopyPROCEDURE

During the therapy protocol, cortical activation measures using the fNIRS method will be conducted every 15 days (at Day0, Day 15, Day 30, Day 45 and Day 60 for 5 sessions in total) at the technical platform of the Grau du Roi physical therapy centre, during the completion of a standardized motor task (maintaining a level of force) using the healthy upper limb and the paretic upper limb.

Also known as: fNIRS
The study population

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient presents with a severe cognitive disorder
  • The patient has severe aphasia with a Boston Diagnostic Aphasia Examination (BDAE) scale score strictly less than 2
  • The patient has heminegligence with a bells test \> 6 on the left.
  • The patient presents with limited amplitude in the paretic upper limb (shoulder abduction \<60°, elbow flexion \> 30° or dorsal wrist flexion \<20°).
  • Imbalanced/uncontrolled epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

Le Grau-du-Roi, 30240, France

Location

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

Related Publications (1)

  • Delorme M, Vergotte G, Perrey S, Froger J, Laffont I. Time course of sensorimotor cortex reorganization during upper extremity task accompanying motor recovery early after stroke: An fNIRS study. Restor Neurol Neurosci. 2019;37(3):207-218. doi: 10.3233/RNN-180877.

    PMID: 31227675RESULT

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy ModalitiesOccupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Jérôme Froger, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 27, 2016

Study Start

February 1, 2016

Primary Completion

August 30, 2016

Study Completion

August 30, 2016

Last Updated

November 19, 2025

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)