UMIN-CTR Clinical Trial

Basic information
Public title	Quantitative analysis of hippotherapy in patients with walking disabilities
Acronym	Evaluation of hippotherapy using quantitative indicators
Scientific Title	Quantitative analysis of hippotherapy in patients with walking disabilities
Scientific Title:Acronym	Evaluation of hippotherapy using quantitative indicators
Region	Japan

Condition
Condition	Patients presented with walking disabilities due to cerebral palsy, hydrocephalus (post-treatment), and stroke.
Classification by specialty	Pediatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Hippotherapy is a treatment strategy that usesequine movement as part of an integrated intervention program for achieving functional outcomes. The aim of this study was to evaluate the effects of hippotherapy on temporospatial parameters of gait and balance abilities in patients with walking disabilities.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Short- and long-term improvement of hippothray assessed by Gross Motor Function Measure (GMFM).Temporospatial parameters of gait and balance abilities using a tri-axial motion recorder analysis for a 5-m or 10-m walikng test, score for dimensions D (standing) and E (walking, running, jumping) of the GMFM. Comparison was performed with control (recreation) or age-matched normal database subjects.
Key secondary outcomes	WHOQOL-BREF (Japanese version), CPQOL-child/-caregiver.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Hippotherapy (30min once weekly)
Interventions/Control_2	Control group without hippotherapy (e.g., recreation, non-therapeutic intervention) or age-matched normal database.
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	4 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Children and adolescents with cerebral palsy in the Kanto region of Japan were recruited by contacting the schools that cater for them with appropriate physiotherapy services, as well as via adjacent hospital/clinics.
Key exclusion criteria	Exclusion criteria included if they had 1) previous participation in hippotherapy, 2) history of fracture or epilepsy within 8 weeks of enrolment, and 3) cognitive or physical impairment sufficiently severe that would hinder study protocol. In addition, participants were excluded if they received medication or orthopedic surgery (e.g., botulinum toxin injection and selective dorsal rhizotomy) for treating tight muscles and spasticity related to CP during the study or within 3 months of the enrollment.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hirokazu Middle name Last name Tsubone
Organization	Graduate School of Agricultural and Life Sciences, The University of Tokyo
Division name	Research Center for Food Safety
Zip code	113-8657
Address	1-1-1 Yayoi, Bunkyo-ku, Tokyo 113-8657, Japan
TEL	03-5841-5004
Email	tsuhiro123@yahoo.co.jp

Public contact
Name of contact person	1st name Tatsushi Middle name Last name Mutoh
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Nuclear Medicine and Radiology
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL	022-717-8559
Homepage URL
Email	tmutoh@tohoku.ac.jp

Sponsor
Institute	Holistic Betterment and Wellness Through Riding PIROUETTE, Japan
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (18K10773)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Holistic Betterment and Wellness Through Riding PIROUETTE
Address	277701 Hiraide-cho, Utsunomiya, Japan
Tel	022-717-8559
Email	tsuhiro123@yahoo.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	SPTS2016007
Org. issuing International ID_1	The Society of Physical Therapy Science Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	障がい者のための馬事普及協会「ピルエット」

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 02 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	30
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	2013 Year 01 Month 01 Day
Date of IRB	2016 Year 12 Month 22 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 02 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026455