UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in pediatric patients with severe motor and intellectual disabilities.
Title of the study (Brief title)	An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in patients with severe motor and intellectual disabilities.
Region	Japan

Condition
Condition	Severe motor and intellectual disabilities
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of a hug as practice of educational therapy for promotion of relaxation in multiple and severely handicapped children who need regular and critical medical care.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	High-Frequency (HF) components by frequency analysis of heart rate variability.
Key secondary outcomes	Low-Frequency (LF)/HF components by frequency analysis of heart rate variability, activity value of salivary amylase, incidence rate of adverse event, appearance change (in facial expression, body movements).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Practice of educational therapy is implemented by a systematic combination of an educational therapist or a nursery teacher who directly performs the therapy (a hug) to the child, an assistant to measure heart rate and activity value of salivary amylase, etc. before and after a hug, and a doctor or a nurse who performs medical observation, once a week for 24 weeks.
Interventions/Control_2
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	Not applicable
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	1) Children with a score of multiple and severely handicapped children of 25 or more. 2) Children who need treatment of tracheotomy or artificial respirator. 3) Children who are 17 years old or younger. 4) Children with lower body weight than 20 kg. 5) Children whose consent for participation in this study is provided by the representative.
Key exclusion criteria	1) Children for whom the principal investigator or other investigators decided not suitable for participation in this study. 2) Children who became multiple and severely handicapped due to traumas of traffic injury, etc.. 3) Children who need sustained continuous suction. 4) Children with a history of bone fracture within 3 years until the time of registration.
Target sample size	20

Research contact person
Name of lead principal investigator	Aritomo Ao
Organization	National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Division name	Educational Therapy
Address	886 Urushiyama, Aoi-ku, Shizuoka, 420-8688, Japan
TEL	054-245-5446
Email	shujidou@shizuokamind.org

Public contact
Name of contact person	Aritomo Ao
Organization	National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Division name	Educational Therapy
Address	886 Urushiyama, Aoi-ku, Shizuoka, 420-8688, Japan
TEL	054-245-5446
Homepage URL
Email	shujidou@shizuokamind.org

Sponsor
Institute	National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

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	青森病院(青森県)、新潟病院(新潟県)、下志津病院(千葉県)、南京都病院(京都府)、静岡てんかん・神経医療センター(静岡県)、豊橋医療センター(愛知県)、東名古屋病院(愛知県)、兵庫あおの病院(兵庫県)、高知病院(高知県)、敦賀医療センター(福井県)、甲府病院(山梨県)、松江医療センター(島根県)、宮崎病院(宮崎県)、四国こどもとおとなの医療センター(香川県)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 02 Day
Anticipated trial start date	2017 Year 02 Month 27 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 26 Day
Last modified on	2018 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029731