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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mackay Memorial Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Mackay Memorial Hospital

Dates:
Date Received: April 20, 2017
Date Started: January 1, 2016
Date Completion:
Last Updated: April 25, 2017
Last Verified: April 2017