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

Primary Purpose

Spasticity

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Focused shock wave
Radial shock wave
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

focused shock wave

radial shock wave

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 20, 2017
Last Updated
April 25, 2017
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03129529
Brief Title
Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Official Title
Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
focused shock wave
Arm Type
Experimental
Arm Description
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.
Arm Title
radial shock wave
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Focused shock wave
Intervention Description
The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
Intervention Type
Device
Intervention Name(s)
Radial shock wave
Intervention Description
The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
Primary Outcome Measure Information:
Title
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
Description
Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
Time Frame
1, 4, 8 week
Secondary Outcome Measure Information:
Title
Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.
Description
Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Time Frame
1, 4, 8 week
Title
Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.
Description
Using the modified Tardieu scale (MTS) to measure the spasticity before treatment and multiple time frame after treatment.
Time Frame
1, 4, 8 week
Title
Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.
Description
Using the baropodometric measurement to measure the foot contact area before treatment and multiple time frame after treatment.
Time Frame
1, 4, 8 week
Title
Change from baseline of gait speed on 8th weeks after treatment.
Description
Using the 10 meters walking test to measure the gait speed before treatment and after treatment.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan

12. IPD Sharing Statement

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

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