UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037292 |
|---|---|
| Receipt number | R000042516 |
| Scientific Title | The investigation on physical and psychological changes by equine-assisted therapy/education in patients with disabilities. |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2022/04/11 11:32:14 |
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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
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
tsuhiro123@yahoo.co.jp
Sponsor or person
Institute
Holistic Betterment and Wellness Through Riding PIROUETTE, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042516
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