Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia

Not Applicable

Completed

• Conditions: Spasticity
• Interventions: Device: Focused shock wave; Device: Radial shock wave

• Registration Number: NCT03129529
• Lead Sponsor: Mackay Memorial Hospital

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-03-01
• Study Completion: 2017-01-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-25
• Last Update Submitted: 2017-04-25
• Study First Posted: 2017-04-26
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
focused shock wave	Focused shock wave	Treatment was administered directly to the middle of muscle bellies of the spastic triceps surae muscle in three sessions, with one week interval. During each session, 3000 pulses (1500 shots in the gastrocnemius and 1500 shots in the soleus muscle) were delivered at 5 Hz. The intensities of FSWT were 0.10 mJ/mm2.
radial shock wave	Radial shock wave	Treatment was administered directly to the middle of muscle bellies of the spastic triceps surae muscle in three sessions, with one week interval. During each session, 3000 pulses (1500 shots in the gastrocnemius and 1500 shots in the soleus muscle) were delivered at 5 Hz.The intensities of RSWT were 2.0 bar.

Primary Outcome Measures

Name	Time	Method
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the modified Tardieu scale (MTS) to measure the spasticity before treatment and multiple time frame after treatment.
Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.	1, 4, 8 week	Using the baropodometric measurement to measure the foot contact area before treatment and multiple time frame after treatment.
Change from baseline of gait speed on 8th weeks after treatment.	8 week	Using the 10 meters walking test to measure the gait speed before treatment and after treatment.

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan