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

The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient

Study Overview

• Status: Completed
• Conditions: Spasticity
• Intervention / Treatment: Device: Focused shock wave; Device: Radial shock wave

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Focused shock wave; The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
Experimental: 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.	Device: Radial shock wave; The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypertonia
• Other Study ID Numbers: 15MMHIS194e

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No