Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome
- Interventions
- Other: Hippotherapy
- Registration Number
- NCT03858023
- Lead Sponsor
- Samsung Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- can sit upright on the static surface
- can follow one step command
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hippotherapy Hippotherapy Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)
- Primary Outcome Measures
Name Time Method Clinical global Impression-Severity of illness (CGI-S) score 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 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
Name Time Method Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score 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 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.
Child Behavior Checklist (CBCL) 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.
PWS (Prader-Willi syndrome) hyperphagia questionnaire 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)
Obesity measured by DEXA (Dual-energy X-ray Absorptiometry) 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.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of