Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:

Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858023
• Other study ID #: 2016-07-058-005
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Samsung Medical Center
• Contact: JI YOUNG CHOI
• Phone: +82-2-3410-3660
• Email: jy210.choi[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Samsung Electronics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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