UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051374 |
|---|---|
| Receipt number | R000058551 |
| Scientific Title | Effects of different intensity of extracorporeal shock wave therapy on upper limb spasticity in stroke patients: a randomized crossover study |
| Date of disclosure of the study information | 2023/06/18 |
| Last modified on | 2023/11/07 19:47:05 |
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Basic information
Public title
Effects of different intensity of extracorporeal shock wave therapy on upper limb spasticity in stroke patients: a randomized crossover study
Acronym
Effects of different intensity of extracorporeal shock wave therapy on upper limb spasticity in stroke patients: a randomized crossover study
Scientific Title
Effects of different intensity of extracorporeal shock wave therapy on upper limb spasticity in stroke patients: a randomized crossover study
Scientific Title:Acronym
Effects of different intensity of extracorporeal shock wave therapy on 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
The purpose of this study is to investigate the effect of different stimulation intensities of rESWT on reducing wrist spasticity in chronic stroke patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
modified Tardieu scale, modified Ashworth scale; Measured before, immediately after, one week, two weeks, three weeks and four weeks after stimulation, respectively
Key secondary outcomes
pain(Visual Analog Scale); immediately after stimulation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-intensity condition; 3,200 shots (1,500 shots to the forearm flexor muscle group) and 800 shots to each interphalangeal muscle of radial extracorporeal shockwave therapy, for a total of 4,700 shots at an intensity of 2.5 Bar.
Interventions/Control_2
Low-intensity condition; 3,200 shots (1,500 shots to the forearm flexor muscle group) and 800 shots to each interphalangeal muscle of radial extracorporeal shockwave therapy, for a total of 4,700 shots at an intensity of 1 Bar.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. the first occurrence of stroke which resulted in unilateral hemiparesis
2. the modified Ashworth scale for the radiocarpal joint >=1
3. at least 12 month of stroke onset
4. the passive range of wrist joint was between 20 palmar flexion and 30 degrees of dorsiflexion
Key exclusion criteria
1. medically unstable
2. receiving muscle relaxant or anti-spastic medication
3. infraction at the cerebellum region
4. cognitive dysfunction as assessed by Hasegawa's Dementia Scale-Revised (score >20)
5. upper limb fracture or non-muscle spasm related restriction of joint movement
6. pacemaker implantation
7. coagulation disorders
8. deep vein thrombosis
9. tumour disease
10.pregnant woman
11. history of seizures and epilepsy
12. skin lesion of the upper extremity
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Nakamura |
Organization
Nishiyamato Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
639-0218
Address
3-2-2 Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
n.junji.0923@gmail.com
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Nakamura |
Organization
Nishiyamato Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
639-0218
Address
3-2-2 Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Homepage URL
n.junji.0923@gmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyanaga Hospital
Address
15-10 Matsumoto-cho, Miyakonojo-city, Miyazaki
Tel
0745-71-6688
n.junji.0923@gmail.com
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
宮永病院(宮崎県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058551
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| Registered date | File name |
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