Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
Primary Purpose
Prader-Willi Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hippotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring hippotherapy, gross motor, balance, behavior
Eligibility 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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hippotherapy
Control
Arm Description
Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)
Children in control group will not receive hippotherapy
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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).
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.
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)
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.
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.
Full Information
NCT ID
NCT03858023
First Posted
August 26, 2016
Last Updated
February 27, 2019
Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
1. Study Identification
Unique Protocol Identification Number
NCT03858023
Brief Title
Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
Official Title
Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
Keywords
hippotherapy, gross motor, balance, behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hippotherapy
Arm Type
Experimental
Arm Description
Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children in control group will not receive hippotherapy
Intervention Type
Other
Intervention Name(s)
Hippotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical global Impression-Severity of illness (CGI-S) score
Description
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
Time Frame
15 weeks
Title
Clinical global Impression-Improvement (CGI-I) score
Description
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.
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score
Description
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).
Time Frame
15 weeks
Title
Pediatric Balance Scale
Description
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.
Time Frame
15 weeks
Title
PWS (Prader-Willi syndrome) hyperphagia questionnaire
Description
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)
Time Frame
15 weeks
Title
Child Behavior Checklist (CBCL)
Description
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.
Time Frame
15 weeks
Title
Obesity measured by DEXA (Dual-energy X-ray Absorptiometry)
Description
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.
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JI YOUNG CHOI
Phone
+82-2-3410-3660
Email
jy210.choi@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD, PHD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD, PHD
Phone
+8210-4591-1039
Email
jeongyi.kwon@samsung.com
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
We'll reach out to this number within 24 hrs