UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048842 |
|---|---|
| Receipt number | R000055653 |
| Scientific Title | A study of the effect of extracorporeal shock wave on spasticity in children (and persons) with severe mental and intellectual disabilities |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/09/03 03:21:50 |
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Basic information
Public title
A study of the effect of extracorporeal shock wave on spasticity in children (and persons) with severe mental and intellectual disabilities
Acronym
A study of the effect of extracorporeal shock wave on spasticity in children (and persons) with severe mental and intellectual disabilities
Scientific Title
A study of the effect of extracorporeal shock wave on spasticity in children (and persons) with severe mental and intellectual disabilities
Scientific Title:Acronym
A study of the effect of extracorporeal shock wave on spasticity in children (and persons) with severe mental and intellectual disabilities
Region
| Japan |
Condition
Condition
Spasticity
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of extracorporeal shock wave on spasticity in children (and persons) with severe mental and intellectual disabilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MAS (modified Ashworth Scale) before and after treatment of extracorporeal shock wave treated muscles
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rehabilitation therapy with extracorporeal shock wave
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
| 2 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients of Tokyo Medical and Dental University Hospital, children (persons) with severe mental and physical disabilities admitted to Tokyo Metropolitan Eastern Ryoikuen and Akitsu Ryoikuen who are receiving rehabilitation treatment
1. those who have a position that is continuously in a bad position due to spasticity.
2. those who have fever, vomiting, weight loss, or are using anticonvulsants on an ad-hoc basis due to spasticity.
Key exclusion criteria
Any of the following conditions will not be covered
1. patients with acute illnesses such as contusions, fractures, cellulitis, etc.
2. Patients who are deemed inappropriate as research subjects by the principal investigator and research assistants
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Medical and Dental University
Division name
Rehabilitation Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bumkyo-ku, Tokyo,Japan
TEL
0358035648
t_sakai.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Medical and Dental University
Division name
Rehabilitation Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bumkyo-ku, Tokyo,Japan
TEL
+81358035648
Homepage URL
t_sakai.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Medical Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bumkyo-ku, Tokyo,Japan
Tel
0358035648
t_sakai.orth@tmd.ac.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
| 2022 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 03 | Day |
Last modified on
| 2022 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055653
