UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Holistic Betterment and Wellness Through Riding PIROUETTE, Japan

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

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

障がい者のための馬事普及協会「ピルエット」

Date of disclosure of the study information

2016

Year

07

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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