UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036272 |
|---|---|
| Receipt number | R000040798 |
| Scientific Title | Effectiveness of Anma massage therapy for body, mood, and social skills in adolescents with autism spectrum disorder: A randomized crossover, two-center pilot study |
| Date of disclosure of the study information | 2019/03/22 |
| Last modified on | 2020/04/03 16:55:21 |
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Basic information
Public title
Effectiveness of Anma massage therapy for body, mood, and social skills in adolescents with autism spectrum disorder: A randomized crossover, two-center pilot study
Acronym
Pilot study of Anma massage therapy for adolescents with ASD
Scientific Title
Effectiveness of Anma massage therapy for body, mood, and social skills in adolescents with autism spectrum disorder: A randomized crossover, two-center pilot study
Scientific Title:Acronym
Pilot study of Anma massage therapy for adolescents with ASD
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder (ASD)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to explore whether continual Anma massage therapy sessions for adolescents with autism spectrum disorder (ASD) can improve their physical condition, mood, and social skills, including ASD-pathognomonic communication problems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Concentration of oxytocin in saliva
Key secondary outcomes
(1) Daily physical complaints, measured using a visual analogue scale
(2) Sensory disorders, measured using the Sensory Profile, 2015
(3) Developmental coordination disorders, measured by the Developmental Coordination Disorder Questionnaire, 2007
(4) Mood state, measured by the Profile of Mood States, 2nd Edition, 2017
(5) Social skills, measured by the Abnormal Behavior Checklist, 2006
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A 20-min whole-body Japanese Anma massage session (excluding face, breasts, and abdomen) was administered once a week for 2 months (8 sessions total). Anma massage therapy is a form of Japanese massage therapy that is performed by comfortable stimulation without pain through the clothing. During a massage, the therapist remains aware that their hands are in close contact with the massage recipient's body. Additionally, the therapist speaks in a soft voice and informs the massage recipient to recognize what part of the body is touched/pressed/kneaded and how strongly.
Interventions/Control_2
Control: No Anma massage intervention
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
| 10 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adolescents diagnosed as having ASD by a medical doctor
Key exclusion criteria
(1) Undergoing treatment or follow-up by a medical doctor for a serious physical or mental illness
(2) Currently receiving Anma massage therapy by professional
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | DONOYAMA |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga, Tsukuba, Ibaraki, 305-8521 Japan
TEL
81+29-858-9631
donoyama@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | DONOYAMA |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga, Tsukuba, Ibaraki, 305-8521 Japan
TEL
81+29-858-9631
Homepage URL
donoyama@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences, Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University of Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology
Address
4-3-15 Amakubo, Tsukuba, Ibaraki, 305-8520 Japan
Tel
81+29-858-9415
kenkyo@ad.tsukuba-tech.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
筑波技術大学（茨城県）、福岡市自閉症協会事務局（福岡県）
Tsukuba University of Technology (Ibaraki, Japan), Office of Association of Autism Spectrum Disorder (Fukuoka, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 22 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 22 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040798
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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