Status:
COMPLETED
Focal Muscular Vibration to Treat Upper Limb Spasticity in Stroke
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Conditions:
Stroke
Eligibility:
All Genders
35-80 years
Phase:
NA
Brief Summary
Spasticity following stroke is one of the most debilitating conditions and has a negative influence on the autonomy and quality of life, and greatly worsens the patient's degree of disability. Focal m...
Detailed Description
Stroke is the major cause of permanent disability with an incidence in Italy of 293 affected persons per 100,000 inhabitants. The onset of spasticity following stroke (20-46%) is one of the most disab...
Eligibility Criteria
Inclusion
- first cerebral stroke
- 2 weeks up to 12 months post the acute event (subacute patients)
- age between 35-80 years
- single cortical or subcortical event
- spastic paresis of the upper limb (Modified Ashworth Scale score ≥ 2)
- ability to give written consent
- compliance with the study procedures
Exclusion
- comorbidities affecting the paretic upper limb (fractures, trauma or peripheral neuropathies)
- cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
- treatment with focal or systemic antispastic drugs (i.e. baclofen, thiocolchicoside, tizanidine).
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04087928
Start Date
September 16 2019
End Date
December 20 2019
Last Update
February 6 2020
Active Locations (1)
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1
Irene Aprile
Roma, Italy, 00166