UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022986 |
|---|---|
| Receipt number | 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 20:15:57 |
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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
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
tmutoh@tohoku.ac.jp
Sponsor or person
Institute
Holistic Betterment and Wellness Through Riding PIROUETTE, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026455
