Early Radial Shock Waves Treatment on Spasticity in Patients With Stroke in Sub-acute Phase
Keywords
Abstract
Dates
Last Verified: | 06/30/2020 |
First Submitted: | 04/19/2020 |
Estimated Enrollment Submitted: | 04/26/2020 |
First Posted: | 04/27/2020 |
Last Update Submitted: | 07/27/2020 |
Last Update Posted: | 07/28/2020 |
Actual Study Start Date: | 05/01/2020 |
Estimated Primary Completion Date: | 08/29/2020 |
Estimated Study Completion Date: | 08/29/2020 |
Condition or disease
Intervention/treatment
Procedure: rSWT group
Procedure: Control group
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: rSWT group Radial Extracorporeal Shock Wave Therapy on spastic muscles of upper limb | Procedure: rSWT group rSWT group: One radial shock wave therapy session a week for 8 weeks (parameters: 1.5 bar, 10 Hz, 2000 shots for each muscle group treated) administered daily during the morning for 40 minutes of conventional rehabilitation treatment. |
Active Comparator: Control group conventional physiotherapy | Procedure: Control group Control group: 40-minutes of conventional rehabilitation treatment 5 days per week in the morning (strength exercise, trunk control exercise, stretching exercise, occupational therapy, and neurodevelopmental facilitation techniques) for 8 weeks |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - 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 Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Change from baseline Modified Ashworth Scale at 9 weeks and at 13 weeks [baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)]
Secondary Outcome Measures
1. Change from baseline FUGL-MEYER ASSESSMENT UPPER EXTREMITY (FMA-UE) at 9 weeks and at 13 weeks [baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)]
2. Change from baseline Barthel Index at 9 weeks and at 13 weeks [baseline the first rSWT treatment, at 9 weeks (1 week after the last treatment) and at 13 weeks (follow up at 4 weeks after the last treatment)]
3. visual analogue scale (VAS) [at 9 weeks (at the end of the last rESWT treatment)]