Back to resultsCortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study (ERASM)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physiotherapy
Occupational therapy
Functional near-infrared spectroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
- CHRU de Montpellier - Hôpital Lapeyronie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The study population
Arm Description
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
Outcomes
Primary Outcome Measures
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Near-infrared spectroscopy signal analysis: the amplitude peak
Near-infrared spectroscopy signal analysis: the amplitude peak
Near-infrared spectroscopy signal analysis: the amplitude peak
Near-infrared spectroscopy signal analysis: the amplitude peak
Near-infrared spectroscopy signal analysis: the amplitude peak
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Near-infrared spectroscopy signal analysis: the laterality index
Near-infrared spectroscopy signal analysis: the laterality index
Near-infrared spectroscopy signal analysis: the laterality index
Near-infrared spectroscopy signal analysis: the laterality index
Near-infrared spectroscopy signal analysis: the laterality index
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Voluntary force: coefficient of variation
Voluntary force refers to the force applied during motricity tasks.
Voluntary force: coefficient of variation
Voluntary force refers to the force applied during motricity tasks.
Voluntary force: coefficient of variation
Voluntary force refers to the force applied during motricity tasks.
Voluntary force: coefficient of variation
Voluntary force refers to the force applied during motricity tasks.
Voluntary force: coefficient of variation
Voluntary force refers to the force applied during motricity tasks.
Fugl-Meyer motricity score
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Fugl-Meyer motricity score
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Fugl-Meyer motricity score
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Fugl-Meyer motricity score
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Fugl-Meyer motricity score
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Secondary Outcome Measures
The Box and Block test: The score is the number of blocks transferred in one minute.
The Box and Block test: The score is the number of blocks transferred in one minute.
The Nine Hole Peg Test: The score is the total time to complete the task.
The Nine Hole Peg Test: The score is the total time to complete the task.
The Barthell test for autonomy
The Barthell test for autonomy
Full Information
NCT ID
NCT02664636
First Posted
January 19, 2016
Last Updated
August 25, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT02664636
Brief Title
Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study
Acronym
ERASM
Official Title
Pilot Study on the Development of Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium in the Post-stroke Early Recovery Phase Evaluated by Functional Near-infrared Spectroscopy (fNIRS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The study population
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Occupational therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Functional near-infrared spectroscopy
Other Intervention Name(s)
fNIRS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Time Frame
Day 0
Title
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Time Frame
Day 15
Title
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Time Frame
Day 30
Title
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Time Frame
Day 45
Title
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Time Frame
Day 60
Title
Near-infrared spectroscopy signal analysis: the amplitude peak
Time Frame
Day 0
Title
Near-infrared spectroscopy signal analysis: the amplitude peak
Time Frame
Day 15
Title
Near-infrared spectroscopy signal analysis: the amplitude peak
Time Frame
Day 30
Title
Near-infrared spectroscopy signal analysis: the amplitude peak
Time Frame
Day 45
Title
Near-infrared spectroscopy signal analysis: the amplitude peak
Time Frame
Day 60
Title
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Time Frame
Day 0
Title
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Time Frame
Day 15
Title
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Time Frame
Day 30
Title
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Time Frame
Day 45
Title
Near-infrared spectroscopy signal analysis: the time required to reach the peak
Time Frame
Day 60
Title
Near-infrared spectroscopy signal analysis: the laterality index
Time Frame
Day 0
Title
Near-infrared spectroscopy signal analysis: the laterality index
Time Frame
Day 15
Title
Near-infrared spectroscopy signal analysis: the laterality index
Time Frame
Day 30
Title
Near-infrared spectroscopy signal analysis: the laterality index
Time Frame
Day 45
Title
Near-infrared spectroscopy signal analysis: the laterality index
Time Frame
Day 60
Title
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 0
Title
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 15
Title
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 30
Title
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 45
Title
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 60
Title
Voluntary force: average
Description
Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Time Frame
Day 0
Title
Voluntary force: average
Description
Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Time Frame
Day 15
Title
Voluntary force: average
Description
Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Time Frame
Day 30
Title
Voluntary force: average
Description
Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Time Frame
Day 45
Title
Voluntary force: average
Description
Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Time Frame
Day 60
Title
Voluntary force: coefficient of variation
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 0
Title
Voluntary force: coefficient of variation
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 15
Title
Voluntary force: coefficient of variation
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 30
Title
Voluntary force: coefficient of variation
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 45
Title
Voluntary force: coefficient of variation
Description
Voluntary force refers to the force applied during motricity tasks.
Time Frame
Day 60
Title
Fugl-Meyer motricity score
Description
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Time Frame
Day 0
Title
Fugl-Meyer motricity score
Description
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Time Frame
Day 15
Title
Fugl-Meyer motricity score
Description
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Time Frame
Day 30
Title
Fugl-Meyer motricity score
Description
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Time Frame
Day 45
Title
Fugl-Meyer motricity score
Description
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
The Box and Block test: The score is the number of blocks transferred in one minute.
Time Frame
Day 0
Title
The Box and Block test: The score is the number of blocks transferred in one minute.
Time Frame
Day 60
Title
The Nine Hole Peg Test: The score is the total time to complete the task.
Time Frame
Day 0
Title
The Nine Hole Peg Test: The score is the total time to complete the task.
Time Frame
Day 60
Title
The Barthell test for autonomy
Time Frame
Day 0
Title
The Barthell test for autonomy
Time Frame
Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme Froger, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
City
Le Grau du Roi
ZIP/Postal Code
30240
Country
France
Facility Name
CHRU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study
We'll reach out to this number within 24 hrs