UMIN-CTR Clinical Trial

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
Email	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
Email	t_sakai.orth@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055653