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

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03129529
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Focused shock wave
  • Device: Radial shock wave
 N/A

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 Design

Study Type:
Interventional
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 :
Jan 1, 2016
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment. [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. [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. [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. [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. [8 week]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mackay Memorial Hospital Taipei Taiwan 104

Sponsors and Collaborators

  • Mackay Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gwo-Chi Hu,PHD, PHD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT03129529
Other Study ID Numbers:
  • 15MMHIS194e
First Posted:
Apr 26, 2017
Last Update Posted:
Apr 26, 2017
Last Verified:
Apr 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Additional relevant MeSH terms:
Muscle Hypertonia

Study Results

No Results Posted as of Apr 26, 2017