Stroke, Acute, Traumatic Brain Injury
Conditions
Brief summary
We propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. Patients will be assessed two weeks, one month, three months and six months after their brain lesion. Secondary objectives: To compare the muscle stiffness and structure of patients who will develop muscle overactivity to patients who won't develop muscle overactivity. To compare the muscle structure and muscle stiffness of the spastic lower limb muscles and the non-spastic lower limb muscles in the affected limb. To compare the muscle structure and muscle stiffness of the affected and the non-affected lower limb. To study the relationship between impairment and function by applying a comprehensive and original method to assess all aspects from muscle structure and mechanics to patient's functional capacities.
Interventions
DIAGNOSTIC_TESTimaging
Magnetic resonance imaging (MRI) Shear wave elastography (SWE) Electronic oscillatory device (EOD)
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female or male ≥ 18 years and ≤ 80 years at screening * Hemiparesis secondary to a first stroke or traumatic brain injury * \< 1 month post-stroke/brain injury Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study.
Exclusion criteria
* Bilateral limb paresis * Major cognitive impairments limiting the functional evaluation * Neurological or orthopedic affection interfering with the paretic limbs function * Underlying neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis) * Contraindication to perform MRI Subjects meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle elasticity | 2 weeks, 1 month, 3 months, 6 months after brain lesion | Muscle elasticity measured by shear wave elastography, expressed in m/s. A smaller shearwave velocity indicates a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| muscle volume | 2 weeks, 1 month, 3 months, 6 months after brain lesion | muscle volume measured by magnetic resonance imaging, expressed in mm3. A greater muscle volume indicates a better outcome |
| muscle fat fraction | 2 weeks, 1 month, 3 months, 6 months after brain lesion | muscle fat fraction measured by magnetic resonance imagine, expressed in % . A smaller fat fraction indicates a better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fugl-meyer score (Lower extremity; motor function) | 2 weeks, 1 month, 3 months, 6 months after brain lesion | maximum score of 34. The highest the score, the better the motor function |
| 10 meter walk test | 2 weeks, 1 month, 3 months, 6 months after brain lesion | Expressed in seconds. A reduced time indicates a better outcome |
| Timed Up And Go | 2 weeks, 1 month, 3 months, 6 months after brain lesion | Expressed in seconds. A reduced time indicates a better outcome |
| passive range of motion | 2 weeks, 1 month, 3 months, 6 months after brain lesion | expressed in angles °. The greater the angle, the better the outcome |
| Abiloco | 2 weeks, 1 month, 3 months, 6 months after brain lesion | maximum score of 13. The highest the score, the better the outcome |
| Stroke Impact Scale | 2 weeks, 1 month, 3 months, 6 months after brain lesion | maximum score of 295. The highest the score, the better the outcome |
| Functional ambulation category | 2 weeks, 1 month, 3 months, 6 months after brain lesion | maximum score of 5. The highest the score, the better the outcome |
| Berg balance scale | 2 weeks, 1 month, 3 months, 6 months after brain lesion | maximum score of 56. The highest the score, the better the balance |
| modified ashworth scale | 2 weeks, 1 month, 3 months, 6 months after brain lesion | minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome |
| modified Tardieu scale | 2 weeks, 1 month, 3 months, 6 months after brain lesion | minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome |
Countries
Belgium
Contacts
Primary ContactMarine Devis, MD
Backup ContactGaetan Stoquart, MD, PhD
Outcome results
None listed