Prader-Willi SyndromeNCT03858023
Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
A study testing Hippotherapy in people with Prader-Willi Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 42 months to 12 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Hippotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- can sit upright on the static surface
- can follow one step command
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
JEONG-YI KWON, MD, PHD, +8210-4591-1039, jeongyi.kwon@samsung.com
JEONG-YI KWON, MD
About this study
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.
Read the 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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Hippotherapy
- Keywords
- hippotherapy, gross motor, balance, behavior
- Medical subject headings
- Prader-Willi Syndrome, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy | Experimental | Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks) Receives: Other: Hippotherapy |
| Control | No intervention | Children in control group will not receive hippotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 15 weeks
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study startAug 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
- Investigators
- JEONG-YI KWON, MD, PHD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858023
- Sponsor's protocol ID
- 2016-07-058-005
- Status last verified
- Feb 2019
- First submitted
- 26 Aug 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT03858023
- Acronym / sponsor ID
- 2016-07-058-005
- Conditions
- Prader-Willi Syndrome
- Keywords
- hippotherapy, gross motor, balance, behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- Aug 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy | Experimental | Other: HippotherapyChildren in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks) |
| Control | No intervention | –Children in control group will not receive hippotherapy |
Who may qualify
- Ages
- 42 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- can sit upright on the static surface
- can follow one step command
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HippotherapyThe 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. | Other | Hippotherapy |
Primary outcome
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.
5 secondary outcomes
Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score
Time frame: 15 weeks
Pediatric Balance Scale
Time frame: 15 weeks
PWS (Prader-Willi syndrome) hyperphagia questionnaire
Time frame: 15 weeks
Child Behavior Checklist (CBCL)
Time frame: 15 weeks
Obesity measured by DEXA (Dual-energy X-ray Absorptiometry)
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JEONG-YI KWON, MD, PHD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy in people with Prader-Willi Syndrome, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JI YOUNG CHOI (+82-2-3410-3660, jy210.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical global Impression-Severity of illness (CGI-S) score (time frame: 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.