Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
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|ClinicalTrials.gov Identifier: NCT03858023|
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prader-Willi Syndrome||Other: Hippotherapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)
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
- 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
- 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.
- 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).
- 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.
- 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)
- 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.
- 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.
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
|Contact: JI YOUNG CHOIfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Contact: JEONG-YI KWON, MD, PHD +8210-4591-1039 email@example.com|
|Principal Investigator: JEONG-YI KWON, MD|
|Principal Investigator:||JEONG-YI KWON, MD, PHD||Samsung Medical Center|