Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

April 19, 2024 updated by: National Taiwan University Hospital Hsin-Chu Branch

The Dose Effectiveness of Extracorporeal Shockwave on Plantar Flexor Spasticity of Ankle in Stroke Patients: a Randomised Controlled Trial

Post-stroke spasticity is a common complication affecting the neurological recovery, self-care daily activities and patients' quality of life. Extracorporeal shock waves (ESWT) have been proven therapeutic effects on decreasing spasticity and regaining function. Stroke patients often suffer ankle plantar flexor spasticity with poor ankle movement control, leading to abnormal gait patterns and risk of falling; local pain appears as well in the ankle. Research showed application of ESWT to lower extremity spasticity reduced ankle plantar flexor spasticity, ankle pain and increased the range of ankle motion. However, the current study did not investigate the effect of ESWT on different muscles in patients with post-stroke ankle spasticity. Therefore, this study will compare the effect of focused ESWT on combination of the gastrocnemius and soleus muscles to gastrocnemius muscle alone in the post-stroke ankle plantar flexor spasticity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study design was a single-blind randomized controlled trial and planned to recruit 40 chronic stroke patients with ankle plantar flexor spasticity. The patients were randomly assigned to two groups. The experimental group received focused ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session), while the control group received focused ESWT to gastrocnemius muscle (2000 shots per session). Patients in both groups underwent a total of 4 sessions ESWT, twice a week for two consecutive weeks. The depths of ESWT to gastrocnemius and soleus muscle were determined by ultrasound. All patients received traditional rehabilitation. The primary outcome was modified Ashworth scale; the secondary outcomes were modified Tardieu scale, passive range of ankle motions and timed up and go test, and ultrasound evaluations (pennation angle and strain elastography of muscles). The outcomes were assessed before ESWT and after ESWT at 1, 4, 12, and 24 week.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yen-Hua Chen, Master
  • Phone Number: 523504 +8863-5326151
  • Email: G54089@hch.gov.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject with Cerebral stroke and age more 20
  2. The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale)
  3. Stable vital sign

Exclusion Criteria:

  1. Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease.
  2. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity.
  3. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave.
  4. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months.
  5. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESWT to gastrocnemius and soleus
ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session)
Device: Extracorporeal shock waves
Both group received extracorporeal shock waves therapy
Active Comparator: ESWT to gastrocnemius
ESWT to gastrocnemius muscle (2000 shots per session)
Device: Extracorporeal shock waves
Both group received extracorporeal shock waves therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Ashworth Scale (MAS)
Time Frame: T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome
T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in modified Tardieu scale (mTS)
Time Frame: T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Modified Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome
T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Change in Level of mobility and balance
Time Frame: T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Timed Up & Go Test
T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Ultrasound evaluations
Time Frame: T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Strain elastography of gastrocnemius muscle
T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Barthel index
Time Frame: T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence.
T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Change in Passive ROM of the ankle in dorsiflexion
Time Frame: T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0
Passive ankle Range of Motion (PROM)
T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Investigators

  • Principal Investigator: Meng Ting Lin, MD, The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-044-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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