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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022986
Receipt No. R000026455
Scientific Title Quantitative analysis of hippotherapy in patients with walking disabilities
Date of disclosure of the study information 2016/07/02
Last modified on 2019/07/01

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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

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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