UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050477 |
|---|---|
| Receipt number | R000057496 |
| Scientific Title | Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2026/09/04 12:02:06 |
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Basic information
Public title
Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients
Acronym
Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients
Scientific Title
Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients
Scientific Title:Acronym
Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether radial extracorporeal shock wave therapy devices promote functional disability, such as spasticity, and improvement in ADLs in stroke patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Modified Ashworth Scale
Key secondary outcomes
Range of motion, Fugl-Meyer Assessment, Functional Independence Measure Motor score, Box and Block Test, 10m Walking Test, Functional Ambulation Categories
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Stroke Hemiplegia
2. Modified Ashworth Scale greater than 1
Key exclusion criteria
Dementia, severe aphasia, severe sensory disturbance or pain, contracture.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyai |
Organization
Morinomiya hospital
Division name
Neurorehabilitation Research Institute
Zip code
5360025
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL
06-6969-0111
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Miyata |
Organization
Morinomiya Hospital
Division name
Officer
Zip code
5360025
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL
06-6969-0111
Homepage URL
miyata@omichikai.or.jp
Sponsor or person
Institute
Morinomiy Hospital
Institute
Department
Personal name
Funding Source
Organization
Sakai Medical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omichi-kai Social Medical Corporation IRB
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
Tel
06-6969-0111
nrri-jimu@omichikai.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s12984-026-01983-y
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s12984-026-01983-y
Number of participants that the trial has enrolled
52
Results
Fifty-two patients with poststroke spasticity within 3 months of stroke onset received radial ESWT to the gastrocnemius and soleus muscles once weekly for 3 weeks. MAS and ankle PROM were assessed before and after each session and at 1 and 5 weeks after treatment. After 3 sessions, MAS decreased by a mean of 0.6 points and PROM increased by 6.4 degrees from baseline. Improvements were maintained for 5 weeks. No serious adverse events occurred.
Results date posted
| 2026 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 05 | Month | 03 | Day |
Baseline Characteristics
Fifty-two patients (19 men and 33 women; mean age, 57.0+/-12.8 years) were analyzed. The mean time from stroke onset to intervention was 59.8+/-23.6 days. Fifteen patients had hemorrhagic stroke and 37 had ischemic stroke. All participants had hemiplegia and ankle spasticity (MAS >1).
Participant flow
Fifty-four patients met the eligibility criteria, and 52 patients were assigned to three groups and completed the study. Two patients discontinued ESWT due to pain or exacerbation of clonus.
Adverse events
Mild adverse events included transient erythema, which resolved spontaneously within a few hours. Muscle contractions and joint movements were observed in a small number of patients during ESWT. One patient experienced exacerbation of clonus and another experienced intolerable pain; both discontinued the intervention. No serious adverse events related to ESWT were observed.
Outcome measures
The outcomes were ankle spasticity and passive range of motion (PROM), assessed using the Modified Ashworth Scale (MAS) and PROM measurements. Assessments were performed before and after each ESWT session and at 1 and 5 weeks after the final session.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057496
