- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01313325
Hippotherapy to Improve the Balance of Children With Movement Disorders (HPOT)
March 10, 2011 updated by: Central Michigan University
Hippotherapy to Improve Balance Deficits in a Cohort of Children With Movement Disorders: A Pilot Study
The purpose of this study is to determine if adding hippotherapy treatment will improve balance for children ages 5-17 who have disabilities such as cerebral palsy and down syndrome.
We also want to find out if by improving their balance the children increase their participation in age appropriate activities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study is to determine the effects of hippotherapy on the balance of children with developmental disorders that cause mild to moderate balance problems.
The secondary purpose is to determine if the use of hippotherapy also improves perceived functional abilities and thus quality of life as measured by the pediatric balance scale and Activities Scale for Kids (respectively)
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Dansville, Michigan, United States, 48854
- CHUM Therapeutic Riding Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- between the ages of 5 and 17
- have a neuromuscular diagnosis or confirmed difficulties with balance
- be able to stand 4 seconds without an assistive device
- be able to follow testing instructions
- must be under 250 pounds
- be able to attend a minimum 10/12 sessions.
Exclusion Criteria:
- any compounding orthopedic or medical condition not related to the primary developmental diagnosis.
- previous hippotherapy intervention or therapeutic riding experience
- allergies or aversion to horses.
- refusal of parents to sign the therapeutic riding center's liability release form
- any new treatments (includes therapies, drugs, or other complementary treatments) within one month of the start of the study or plans for new treatments during the intervention period
- lack of a physician referral for physical therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment group
Children between 5-17 years who have balance deficits related to any movement disorder (preferably neuromuscular)
|
Children will receive treatment by a licensed physical therapist using hippotherapy as the treatment strategy.
This includes sitting on a horse who's movement is controlled by a horse leader, with the PT directing the movements required of the horse, as well as supplying supplemental cues to the participant.
Alternative positions (such as sitting backward and sideways) may also be used during the treatment session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Balance Scale
Time Frame: 8-9 weeks
|
The Pediatric Balance Scale (PBS) is a standardized 14 item test of various component activities related to balance.
It is a modified child version of the adult Berg Balance Scale.
The PBS has high total score test-retest reliability of ICC (3,1) =0.998, as well as good interrater reliability (ICC(3,1) = 0.997).1
|
8-9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activities Scale for Kids
Time Frame: 8-9 weeks
|
Activities Scale for Kids - Participation (ASKp) is a self-administered 30 item questionaire that measures the impact of children's disability to overall function and participation within relevant environments.
It correlates well with parent reports on the Childhood Health Assessment Questionnaire (r=0.81,
p<0.000) and clinician observations of children's function (ICC=0.92,
p<0.000).
|
8-9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Debbie J Silkwood-Sherer, PT, DHS, Central Michigan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: 10.1016/j.apmr.2009.01.011.
- Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004 Fall;16(3):165-72. doi: 10.1097/01.PEP.0000136003.15233.0C.
- Silkwood-Sherer D, Warmbier H. Effects of hippotherapy on postural stability, in persons with multiple sclerosis: a pilot study. J Neurol Phys Ther. 2007 Jun;31(2):77-84. doi: 10.1097/NPT.0b013e31806769f7.
- Benda W, McGibbon NH, Grant KL. Improvements in muscle symmetry in children with cerebral palsy after equine-assisted therapy (hippotherapy). J Altern Complement Med. 2003 Dec;9(6):817-25. doi: 10.1089/107555303771952163.
- Silkwood-Sherer D. Hippotherapy as an Intervention to Improve Postural Control of Children with Movement Disorders. Dev Med Child Neurol 51(S5):18-19, 2009 [abstract]
- Silkwood-Sherer DJ, Killian CB, Long TM, Martin KS. Hippotherapy--an intervention to habilitate balance deficits in children with movement disorders: a clinical trial. Phys Ther. 2012 May;92(5):707-17. doi: 10.2522/ptj.20110081. Epub 2012 Jan 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
March 9, 2011
First Submitted That Met QC Criteria
March 10, 2011
First Posted (Estimate)
March 11, 2011
Study Record Updates
Last Update Posted (Estimate)
March 11, 2011
Last Update Submitted That Met QC Criteria
March 10, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Intellectual Disability
- Neurodevelopmental Disorders
- Abnormalities, Multiple
- Chromosome Disorders
- Cerebral Palsy
- Disease
- Down Syndrome
- Movement Disorders
- Motor Skills Disorders
- Neuromuscular Diseases
Other Study ID Numbers
- 09/14/2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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