Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

Study Overview
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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.

Official Title
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Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

Conditions
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Prader-Willi Syndrome

Intervention / Treatment
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* Other: Hippotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hippotherapy<br>Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks) | Other: Hippotherapy<br>* 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.<br>|
| No Intervention: Control<br>Children in control group will not receive hippotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score | 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). | 15 weeks | 
| Pediatric Balance Scale | 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. | 15 weeks | 
| PWS (Prader-Willi syndrome) hyperphagia questionnaire | 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) | 15 weeks | 
| Child Behavior Checklist (CBCL) | 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. | 15 weeks | 
| Obesity measured by DEXA (Dual-energy X-ray Absorptiometry) | 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. | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hippotherapy, gross motor, balance, behavior