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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036272
Receipt No. 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 2019/03/22

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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
Email 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
Email donoyama@k.tsukuba-tech.ac.jp

Sponsor
Institute Faculty of Health Sciences, Tsukuba University of Technology
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040798

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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