Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: Physiotherapy; Procedure: Occupational therapy; Procedure: Functional near-infrared spectroscopy

• Registration Number: NCT02664636
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

The secondary objectives of this study are:

A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from Day 0 to Day 60.

B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Study Start: 2016-02
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population	Occupational therapy	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
The study population	Functional near-infrared spectroscopy	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
The study population	Physiotherapy	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

Primary Outcome Measures

Name	Time	Method
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation	Day 60
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength	Day 60	Voluntary force refers to the force applied during motricity tasks.
Near-infrared spectroscopy signal analysis: the time required to reach the peak	Day 60
Voluntary force: average	Day 60	Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Voluntary force: coefficient of variation	Day 60	Voluntary force refers to the force applied during motricity tasks.
Near-infrared spectroscopy signal analysis: the amplitude peak	Day 60
Near-infrared spectroscopy signal analysis: the laterality index	Day 60
Fugl-Meyer motricity score	Day 60	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

Secondary Outcome Measures

Name	Time	Method
The Nine Hole Peg Test: The score is the total time to complete the task.	Day 60
The Box and Block test: The score is the number of blocks transferred in one minute.	Day 60
The Barthell test for autonomy	Day 60

Trial Locations

Locations (2)

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi; 🇫🇷 Le Grau du Roi, France