UMIN-CTR Clinical Trial

Basic information
Public title	The Effectiveness of Dance Movement Therapy for Children and Adults with Williams Syndrome
Acronym	The Effectiveness of Dance Movement Therapy for Children and Adults with Williams Syndrome
Scientific Title	The Effectiveness of Dance Movement Therapy for Children and Adults with Williams Syndrome
Scientific Title:Acronym	The Effectiveness of Dance Movement Therapy for Children and Adults with Williams Syndrome
Region	Japan

Condition
Condition	Williams Syndrome
Classification by specialty	Pediatrics Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effectiveness of Dance/Movement Therapy for children and adult with Williams Syndrome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Center of Gravity Sway, Hand Held Dynamometer(HHD), Timed Up and Go(TUG), Adult Behavior Checklist(ABCL), Child Behavior Checklist(CBCL), Teacher's Report Form(TRF), Manifest Anxiety Scale(MAS), Children's Manifest Anxiety Scale(CMAS)
Key secondary outcomes	Saliva Amylase

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Dance Movement Therapy
Interventions/Control_2	Dance Movement Therapy
Interventions/Control_3	No Interventions
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	3 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	1)People identified as Williams Syndrome age from 3 to 40 2)People identified as intellectual disorder age from 3 to 40
Key exclusion criteria	1)Children with a diagnosis of epilepsy 2)Children and adults who diagnosed as having the difficulty of active exercise by a doctor 3)Children and adults with a diagnosis of mental illness 4)Children and adults who are difficult to respond to instructions due to visual impairment or hearing impairment
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshihiro Kato
Organization	Human Health Science, Graduate School of Medicine, Kyoto University
Division name	Department of Brain Function and Rehabilitation
Zip code
Address	53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3819
Email	Kato.toshihiro.5z@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideki Takahashi
Organization	Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name	Department of Brain Function and Rehabilitation
Zip code
Address	53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3819
Homepage URL
Email	takahashi.hideki.66z@st.kyoto-u.ac.jp

Sponsor
Institute	Department of Brain Function and Rehabilitation, Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 03 Month 13 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	2018 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 13 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036210

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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