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Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858023
Recruitment Status : Unknown
Verified February 2019 by Jeong Yi Kwon, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Samsung Electronics
Information provided by (Responsible Party):
Jeong Yi Kwon, Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Other: Hippotherapy Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
Study Start Date : August 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hippotherapy
Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)
 Other: 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.
No Intervention: Control
Children in control group will not receive hippotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Clinical global Impression-Severity of illness (CGI-S) score [ Time Frame: 15 weeks ]
    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

  2. Clinical global Impression-Improvement (CGI-I) score [ Time Frame: 15 weeks ]
    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.


Secondary Outcome Measures :
  1. Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score [ Time Frame: 15 weeks ]
    The 88 items of the GMFM are measured by observation of the child and scored on a 4-point ordinal scale (0=does not initiate, 1=initiates <10% of activity, 2=partially completes 10% to <100% of activity, 3=completes activity). The items are weighted equally and grouped into 5 dimensions: (1) lying and rolling (17 items), (2) sitting (20 items), (3) crawling and kneeling (14 items), (4) standing (13 items), and (5) walking, running, jumping (24 items).

  2. Pediatric Balance Scale [ Time Frame: 15 weeks ]
    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

  3. PWS (Prader-Willi syndrome) hyperphagia questionnaire [ Time Frame: 15 weeks ]
    The Hyperphagia Questionnaire is a robust tool for relating breakthroughs in the neurobiology of hyperphagia to in vivo food-seeking behavior and for examining the psychological and developmental correlates of hyperphagia in PWS. It has 13 items and rated on a five-point scale (1 = not a problem to 5 = severe and/or frequent problem)

  4. Child Behavior Checklist (CBCL) [ Time Frame: 15 weeks ]
    The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. CBCL asks caregivers to rate 112 problems on a three-point scale (0 not true, 1 somewhat true, 2 very true). It provides an internalizing and externalizing domain.

  5. Obesity measured by DEXA (Dual-energy X-ray Absorptiometry) [ Time Frame: 15 weeks ]
    Dual-energy X-ray Absorptiometry is a means of measuring bone mineral density (BMD). Two X-ray beams, with different energy levels, are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Dual-energy X-ray absorptiometry is the most widely used and most thoroughly studied bone density measurement technology.


Eligibility Criteria
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Ages Eligible for Study:   42 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858023


Contacts
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Contact: JI YOUNG CHOI +82-2-3410-3660 jy210.choi@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: JEONG-YI KWON, MD, PHD    +8210-4591-1039    jeongyi.kwon@samsung.com   
Principal Investigator: JEONG-YI KWON, MD         
Sponsors and Collaborators
Samsung Medical Center
Samsung Electronics
Investigators
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Principal Investigator: JEONG-YI KWON, MD, PHD Samsung Medical Center
More Information
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Responsible Party: Jeong Yi Kwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03858023    
Other Study ID Numbers: 2016-07-058-005
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Yi Kwon, Samsung Medical Center:
hippotherapy
gross motor
balance
behavior
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders