Stroke
Conditions
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.
Interventions
PROCEDUREOccupational therapy
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.
PROCEDUREPhysiotherapy
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.
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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer motricity score | Day 0 | The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills. |
| Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength | Day 0 | Voluntary force refers to the force applied during motricity tasks. |
| Voluntary force: average | Day 0 | 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 0 | Voluntary force refers to the force applied during motricity tasks. |
| Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation | Day 0 | — |
| Near-infrared spectroscopy signal analysis: the amplitude peak | Day 0 | — |
| Near-infrared spectroscopy signal analysis: the time required to reach the peak | Day 0 | — |
| Near-infrared spectroscopy signal analysis: the laterality index | Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| The Nine Hole Peg Test: The score is the total time to complete the task. | Day 0 |
| The Barthell test for autonomy | Day 0 |
| The Box and Block test: The score is the number of blocks transferred in one minute. | Day 0 |
Countries
France
Outcome results
None listed