Stroke
Conditions
Keywords
1- Constraint induced therapy, 2- Stroke, 3- Upper limb, 4- Rehabilitation, 5- Motor training, 1- First time clinical ischemic or hemorrhagic stroke, 2- At least 10° of active wrist extension, 3- At least 10° of thumb abduction/ extension, 4- At least 10° of extension in at least 2 additional digits, 3- Adequate balance while wearing the restraint.
Brief summary
The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.
Detailed description
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit. The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist). Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.
Interventions
OTHERLight constraint induced therapy
90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
OTHERStandard constraint induced therapy
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * First ischemic or hemorrhagic stroke between 2 and 12 months * at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits. * adequate balance while wearing the restraint
Exclusion criteria
* Major cognitive impairment * Prior stroke * Excessive fatigability * Severe aphasia * MAL score ≥ 2,5 * Specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motor activity log scale | 10 days before inclusion, 10 days and 3 months after treatment achievement |
Secondary
| Measure | Time frame |
|---|---|
| Wolf Motor Function test Stroke impact scale Functional MRI HAD scale | 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month) |
Countries
France
Outcome results
None listed