Status:
TERMINATED
Early Radial Shock Waves Treatment on Spasticity in Patients With Stroke in Sub-acute Phase
Lead Sponsor:
Stefano Brunelli
Conditions:
Spasticity, Muscle
Extracorporeal Shockwave Therapy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Hands and wrist spasticity are a common post stroke complication and often lead to restrictions in daily living activities. Spasticity causes changes in muscle composition such as accumulation of coll...
Eligibility Criteria
Inclusion
- Diagnosis of hemiparesis after an ischemic or hemorrhagic stroke
- Onset of spasticity within 3 months from acute stroke
- First-stroke survivors with confirmed brain lesions by tomography or magnetic resonance imaging
- Adults (age between 18 and 80 years)
- Post-stroke upper limb spasticity ranging 1-4 according to the Modified Ashworth Scale
Exclusion
- No treatment of the limb spasticity with botulinum toxin, phenol, alcohol, or surgery in the last 6 months
- Presence of an unstable medical condition
- Contraindications to shock waves treatment (pregnancy, cancer, coagulopathies, pacemakers, skin pathologies)
- Global aphasia
- All subjects who scored above 25 on the Mini-Mental State Examination
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04365478
Start Date
May 2 2020
End Date
September 27 2021
Last Update
April 1 2022
Active Locations (1)
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1
Stefano Brunelli
Roma, Italy, 00179