NCT03858023

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

August 26, 2016

Last Update Submit

February 27, 2019

Conditions

Prader-Willi Syndrome

Keywords

hippotherapygross motorbalancebehavior

Outcome Measures

Primary Outcomes (2)

  • Clinical global Impression-Severity of illness (CGI-S) score

    The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The two components of CGI were used in this study: Severity of Illness (CGI-S) and Global improvement (CGI-I). The clinician rates CGI-S on a 7-point scale from 1(normal) to 7(extremely ill) Thus, higher score means more severity outcomes

    15 weeks

  • Clinical global Impression-Improvement (CGI-I) score

    The clinician rates CGI-I on a 7-point scale from 1(very much improved) to 7(very much worse) respectively. Thus, higher score means worse outcomes.

    15 weeks

Secondary Outcomes (5)

  • Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score

    15 weeks

  • Pediatric Balance Scale

    15 weeks

  • PWS (Prader-Willi syndrome) hyperphagia questionnaire

    15 weeks

  • Child Behavior Checklist (CBCL)

    15 weeks

  • Obesity measured by DEXA (Dual-energy X-ray Absorptiometry)

    15 weeks

Study Arms (2)

Hippotherapy

EXPERIMENTAL

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

Other: Hippotherapy

Control

NO INTERVENTION

Children in control group will not receive hippotherapy

Interventions

HippotherapyOTHER

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.

Hippotherapy

Eligibility Criteria

Age42 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Prader-Willi SyndromeBehavior

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • JEONG-YI KWON, MD, PHD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JI YOUNG CHOI

CONTACT

+82-2-3410-3660jy210.choi@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2016

First Posted

February 28, 2019

Study Start

August 1, 2016

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)