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

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ClinicalTrials.gov Identifier: NCT03129529
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gwo-Chi Hu,PHD, 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

Condition or disease Intervention/treatment Phase
Spasticity Device: Focused shock wave Device: Radial shock wave Not Applicable

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129529


Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Mackay Memorial Hospital

Responsible Party: Gwo-Chi Hu,PHD, PHD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03129529     History of Changes
Other Study ID Numbers: 15MMHIS194e
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No