Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
Study Overview
Brief Summary
The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient
Detailed Description
This study is a prospective and double-blinded randomized control trial. Thirty-two stroke patients with spastic equinus were randomly assigned to receive three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals. The intensities that were used during FSWT (0.1 mJ/mm2) and RSWT (2 bar) were comparable. Patients were evaluated at baseline and at 1, 4, 8 weeks after the final shockwave treatment. The primary outcome measure was modified Ashworth scale (MAS) score. Secondary outcome measures were Tardieu scale, ankle passive range of motion, plantar contact area during gait, and gait speed. A linear mixed model with repeated measures was used to compare each outcome measure between the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged greater than 18 years old;
- •at least 6 months since onset of last stroke;
- •triceps surae muscle tone graded at least 1+ on the Modified Ashworth Scale (MAS) score;
- •ability to walk alone with/without orthosis.
Exclusion Criteria
- •Exclusion criteria included fixed ankle joint contracture, previous treatment of the affected leg with neurolytic or surgical procedures, concomitant progressive central nervous system diseases, and skin breakdown, vascular disease in the affected leg
Outcomes
Primary Outcomes
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
Time Frame: 1, 4, 8 week
Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
Secondary Outcomes
- Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.(1, 4, 8 week)
- Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.(1, 4, 8 week)
- Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.(1, 4, 8 week)
- Change from baseline of gait speed on 8th weeks after treatment.(8 week)
Investigators
Gwo-Chi Hu,PHD
PHD
Mackay Memorial Hospital