Hippotherapy to Improve the Balance of Children With Movement Disorders (HPOT)
| Tracking Information | |||||
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| First Received Date ICMJE | March 9, 2011 | ||||
| Last Updated Date | March 10, 2011 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pediatric Balance Scale [ Time Frame: 8-9 weeks ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01313325 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Activities Scale for Kids [ Time Frame: 8-9 weeks ] [ Designated as safety issue: No ] 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). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hippotherapy to Improve the Balance of Children With Movement Disorders | ||||
| Official Title ICMJE | Hippotherapy to Improve Balance Deficits in a Cohort of Children With Movement Disorders: A Pilot Study | ||||
| Brief Summary | 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. |
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| 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) |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Hippotherapy
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. |
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| Study Arm (s) | Experimental: Treatment group
Children between 5-17 years who have balance deficits related to any movement disorder (preferably neuromuscular)
Intervention: Other: Hippotherapy |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01313325 | ||||
| Other Study ID Numbers ICMJE | 09/14/2006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Debbie Silkwood-Sherer, Central Michigan University | ||||
| Study Sponsor ICMJE | Central Michigan University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Central Michigan University | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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