Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

NCT ID: NCT03858023

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

Detailed Description

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This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

The primary purpose of this study is to investigate effect of hippotherapy on motor function of Prader-Willi syndrome patients.

The secondary purpose is to compare motor function, obesity, and behavior of the children after the intervention with those parameters before the intervention.

Conditions

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Prader-Willi Syndrome

Keywords

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hippotherapy gross motor balance behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hippotherapy

Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)

Group Type EXPERIMENTAL

Hippotherapy

Intervention Type OTHER

The hippotherapy program consists of 2 sessions per week for 15 weeks. One session is 30-minute session. The program involves 2 therapists and 3 personnel for safety issues.

Control

Children in control group will not receive hippotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hippotherapy

The hippotherapy program consists of 2 sessions per week for 15 weeks. One session is 30-minute session. The program involves 2 therapists and 3 personnel for safety issues.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* can sit upright on the static surface
* can follow one step command

Exclusion Criteria

* body wight \> 35 kg
* serious medical conditions such as cardiac disease, pulmonary disease, uncontrolled epilepsy
* visual impairment, hearing impairment
* bleeding tendency, anticoagulation
* fracture within 6 months, major orthopedic surgery within 1 year
Minimum Eligible Age

42 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Electronics

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JEONG-YI KWON, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JI YOUNG CHOI

Role: CONTACT

Phone: +82-2-3410-3660

Email: [email protected]

Facility Contacts

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JEONG-YI KWON, MD, PHD

Role: primary

Other Identifiers

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2016-07-058-005

Identifier Type: -

Identifier Source: org_study_id