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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000031711 |
Receipt No. | R000036210 |
Scientific Title | The Effectiveness of Dance Movement Therapy for Children and Adults with Williams Syndrome |
Date of disclosure of the study information | 2018/03/13 |
Last modified on | 2018/03/13 |
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 |
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Condition | ||||
Condition | Williams Syndrome | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Kato.toshihiro.5z@kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |