Skip to main content
OpenTrials
Completed

NCT Number: NCT03129529

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

Taipei, 104, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focused shock wave

Device

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

Device

The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.

Primary outcomes

  1. 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

  1. Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.

    Time frame: 1, 4, 8 week

    Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.

  2. Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.

    Time frame: 1, 4, 8 week

    Using the modified Tardieu scale (MTS) to measure the spasticity before treatment and multiple time frame after treatment.

  3. Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.

    Time frame: 1, 4, 8 week

    Using the baropodometric measurement to measure the foot contact area before treatment and multiple time frame after treatment.

  4. Change from baseline of gait speed on 8th weeks after treatment.

    Time frame: 8 week

    Using the 10 meters walking test to measure the gait speed before treatment and after treatment.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 26, 2017
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.