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Comparison of Extracorporeal Shock Wave to Different Muscle Targets in Post-Stroke Spasticity of Ankle Plantar Flexor

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracorporeal shock waves
Sponsored by
National Taiwan University Hospital Hsin-Chu Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, spasticity, shock wave, ankle

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject with Cerebral stroke and age more 20 The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale) Stable vital sign Exclusion Criteria: Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.

Sites / Locations

  • National Taiwan University Hospital Hsin-Chu BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ESWT to gastrocnemius and soleus

ESWT to gastrocnemius

Arm Description

ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session)

ESWT to gastrocnemius muscle (2000 shots per session)

Outcomes

Primary Outcome Measures

Change in Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome
Change in modified Tardieu scale (mTS)
Modified Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome
Change in Passive ROM of the ankle in dorsiflexion
Passive ankle Range of Motion (p-ROM)

Secondary Outcome Measures

Change in Level of mobility and balance
Timed Up & Go Test
Ultrasound evaluations
Pennation angle of muscles
Ultrasound evaluations
Strain elastography of gastrocnemius muscle

Full Information

First Posted
January 3, 2023
Last Updated
June 8, 2023
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
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1. Study Identification

Unique Protocol Identification Number
NCT05878223
Brief Title
Comparison of Extracorporeal Shock Wave to Different Muscle Targets in Post-Stroke Spasticity of Ankle Plantar Flexor
Official Title
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital Hsin-Chu Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, spasticity, shock wave, ankle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
participants
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESWT to gastrocnemius and soleus
Arm Type
Experimental
Arm Description
ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session)
Arm Title
ESWT to gastrocnemius
Arm Type
Active Comparator
Arm Description
ESWT to gastrocnemius muscle (2000 shots per session)
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock waves
Intervention Description
Both group received extracorporeal shock waves therapy
Primary Outcome Measure Information:
Title
Change in Modified Ashworth Scale (MAS)
Description
Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome
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
Title
Change in modified Tardieu scale (mTS)
Description
Modified Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome
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
Title
Change in Passive ROM of the ankle in dorsiflexion
Description
Passive ankle Range of Motion (p-ROM)
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
Secondary Outcome Measure Information:
Title
Change in Level of mobility and balance
Description
Timed Up & Go Test
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
Title
Ultrasound evaluations
Description
Pennation angle of muscles
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
Title
Ultrasound evaluations
Description
Strain elastography of gastrocnemius muscle
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with Cerebral stroke and age more 20 The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale) Stable vital sign Exclusion Criteria: Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Hua Chen, Master
Phone
+8863-5326151
Ext
523504
Email
G54089@hch.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-mei Yang, MD
Phone
0972653754
Email
b99401109@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Ting Lin, MD
Organizational Affiliation
The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Hsin-Chu Branch
City
Hsinchu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-mei Yang, MD
Phone
0972653754
Email
b99401109@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21707868
Citation
Ward AB. A literature review of the pathophysiology and onset of post-stroke spasticity. Eur J Neurol. 2012 Jan;19(1):21-7. doi: 10.1111/j.1468-1331.2011.03448.x. Epub 2011 Jun 27.
Results Reference
background
PubMed Identifier
19601786
Citation
Mariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. doi: 10.2174/092986709788682119.
Results Reference
background
PubMed Identifier
28971038
Citation
Yoon SH, Shin MK, Choi EJ, Kang HJ. Effective Site for the Application of Extracorporeal Shock-Wave Therapy on Spasticity in Chronic Stroke: Muscle Belly or Myotendinous Junction. Ann Rehabil Med. 2017 Aug;41(4):547-555. doi: 10.5535/arm.2017.41.4.547. Epub 2017 Aug 31.
Results Reference
background
PubMed Identifier
34566855
Citation
Fan T, Zhou X, He P, Zhan X, Zheng P, Chen R, Li R, Li R, Wei M, Zhang X, Huang G. Effects of Radial Extracorporeal Shock Wave Therapy on Flexor Spasticity of the Upper Limb in Post-stroke Patients: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Sep 9;12:712512. doi: 10.3389/fneur.2021.712512. eCollection 2021.
Results Reference
background
PubMed Identifier
27149465
Citation
Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
Results Reference
result

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Comparison of Extracorporeal Shock Wave to Different Muscle Targets in Post-Stroke Spasticity of Ankle Plantar Flexor

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