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

Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129529
• Other study ID #: 15MMHIS194e
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: April 25, 2017
• Start date: January 1, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: April 2017
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2017
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spasticity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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