UMIN-CTR Clinical Trial

Basic information
Public title	The investigation on physical and psychological changes by equine-assisted therapy/education in patients with disabilities.
Acronym	Physical and psychological effects of hippotherapy
Scientific Title	The investigation on physical and psychological changes by equine-assisted therapy/education in patients with disabilities.
Scientific Title:Acronym	Physical and psychological effects of hippotherapy
Region	Japan

Condition
Condition	Stroke, Autism Spectrum Disorder(ASD), Cerebral Palsy(CP)
Classification by specialty	Rehabilitation medicine Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to elucidate the significance of equine-assisted therapy and education in patients with stroke, ASD, and CP through scientific evaluation on their physical and mental changes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The modified Rankin Scale(mRS), Gross Motor Function Classification System(GMFCS), and Childhood Autism Rating Scale(CARS) are used for outcomes in stroke, cerebral palsy, and autism spectrum disease(ASD), respectively. Measurements: 10m-walking test and timed up and go test are performed for stroke and cerebral palsy patients, respectively. In the walking test, the gait exercise ability and movement of each part of body are analyzed by two-dimensional image analysis. In the TUG test, the performance time while a participant stands up from a chair and sits down accompanied by 3m-walk turn is measured.
Key secondary outcomes	GMFM is used for cerebral palsy, while ABC is for ASD. 1n some patients with stroke the stabilometry test is performed.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Hippotherapy(basically 20min. once week)
Interventions/Control_2	Control group without hippotherapy or age-mached 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	6 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Stroke Basically patients over 2 years after onset ASD Hippotherapy group: patients aging 6 to <16 years, who were diagnosed as autism spectrum disease by medical institutes. These patients are assigned for horse-riding program. Control group: patients with the same ages as the hippotherapy group, who were diagnosed as autism spectrum disease by medical institutes. These patients are subjected to regular therapeutic program without horse-riding. CP Patients aging 6 to <30 years, who were diagnosed as cerebral palsy by medical institutes. These patients are assigned for horse-riding program.
Key exclusion criteria	1.Patients with hypertension, epilepsy, arrhythmia, osteoporosis and severe scoliosis 2.Patients with severe instability of the head 3.Patients with surgical treatments of joints and/or tendons 4.Patients who once experienced horse-riding lessons 5.Patients who have been received other special treatments 6.Patients who were subjected to change the design of treatment program during participation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Ihara
Organization	Teikyo University
Division name	Faculty of Medical Technology
Zip code	320-0003
Address	1-1 Toyosatodai, Utsunomiya, Tochigi 320-0003, Japan
TEL	028-627-7111
Email	ihara331@aol.com

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Tsubone
Organization	Holistic Betterment and Wellness Through Riding PIROUETTE, Japan
Division name	Research organizer
Zip code	321-0921
Address	2777-1 Hiraide, Utsunomiya, Tochigi 321-0921, Japan
TEL	080-8908-4763
Homepage URL
Email	tsuhiro123@yahoo.co.jp

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

Funding Source
Organization	National Riding Club Association of Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee, Teikyo University
Address	2-11-1 Kaga, Itabashi, Tokyo 173-8605, Japan
Tel	03-3964-7256
Email	turb-office@teikyo-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	2019 Year 07 Month 10 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	35
Results	Stroke and cerebral palsy cases Gait performance tests: The increase in stride length and the shortening of performance time in Timed-up and Go test were observed in patients with riding programs. Development disability cases ABC-J scores in subscales of excitatory, lethargy and hyperactivity were significantly changed during the observation period in participants with riding programs.
Results date posted	2022 Year 03 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Stroke patients(male, female) Children with cerebral palsy(male, female) and developmental disorders(male, female)
Participant flow	Participants who signed the informed consent or informed assent were recruited in this study.
Adverse events	none
Outcome measures	Gait functions(stroke patients, CP children) and psychological functions(children with developmental disorders)
Plan to share IPD	none
IPD sharing Plan description	none

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 06 Month 10 Day
Date of IRB	2019 Year 06 Month 17 Day
Anticipated trial start date	2019 Year 07 Month 06 Day
Last follow-up date	2022 Year 02 Month 25 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 04 Month 01 Day
Date analysis concluded	2022 Year 04 Month 10 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 06 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042516