UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031711 |
|---|---|
| Receipt number | 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 | 2024/03/18 15:58:26 |
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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 | Toshihiro |
| Middle name | |
| Last name | Kato |
Organization
Human Health Science, Graduate School of Medicine, Kyoto University
Division name
Department of Brain Function and Rehabilitation
Zip code
606-8507
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
| 1st name | Hideki |
| Middle name | |
| Last name | Takahashi |
Organization
Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
Department of Brain Function and Rehabilitation
Zip code
606-8507
Address
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3819
Homepage URL
takahashi.hideki.66z@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Brain Function and Rehabilitation, Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
Kyoto University Certified Review Board
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2018 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jir.13033
Number of participants that the trial has enrolled
31
Results
Pre-intervention assessments showed that there was no a significant difference between intervention and control groups. Even though there were no significant interaction in static balance, and maladaptive functioning and behavioral problems, the result of dynamic balance showed a interaction and large effect sizes [(f(1, 29) = 4.52, P = 0.04, np2 = 0.14)] . Moreover, the intervention group showed a statistically significant difference between the posttest and the pretest (P = 0.00).
Results date posted
| 2024 | Year | 03 | Month | 18 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036210
