Neuromuscular DiseasesHPOTNCT01313325
Hippotherapy to Improve the Balance of Children With Movement Disorders
A study testing Hippotherapy in people with Neuromuscular Diseases and Cerebral Palsy, run by Central Michigan University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Neuromuscular Diseases, Cerebral Palsy, Down Syndrome
- What is being tested?
- Hippotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2007
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CHUM Therapeutic Riding Center
Dansville, Michigan, 48854
About this study
Official title: 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.
Read the 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)
- Conditions
- Neuromuscular Diseases, Cerebral Palsy, Down Syndrome, Autism, Developmental Coordination Disorder
- Being tested
- Hippotherapy
- Keywords
- hippotherapy, neuromuscular disorders, balance deficits, participation
- Medical subject headings
- Neuromuscular Diseases, Cerebral Palsy, Down Syndrome, Autistic Disorder, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Children between 5-17 years who have balance deficits related to any movement disorder (preferably neuromuscular) Receives: Other: Hippotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
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
Measured: 8-9 weeks
Secondary outcomes (1)
Activities Scale for Kids
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).
Measured: 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Michigan University
- Sponsor type
- University, hospital or other
- Investigators
- Debbie J Silkwood-Sherer, PT, DHS, Principal investigator, Central Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313325
- Sponsor's protocol ID
- 09/14/2006
- Acronym
- HPOT
- Status last verified
- Mar 2011
- First submitted
- 9 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19480872Casady 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.
PubMed 17057544Benda 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.
PubMed 14736353Silkwood-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.
PubMed 17558361Silkwood-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.
PubMed 22247403
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippotherapy to Improve Balance Deficits in a Cohort of Children With Movement Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT01313325
- Acronym / sponsor ID
- HPOT / 09/14/2006
- Conditions
- Neuromuscular Diseases, Cerebral Palsy, Down Syndrome, Autism, Developmental Coordination Disorder
- Keywords
- hippotherapy, neuromuscular disorders, balance deficits, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Central Michigan UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Mar 2011 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: HippotherapyChildren between 5-17 years who have balance deficits related to any movement disorder (preferably neuromuscular) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| HippotherapyChildren 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. | Other | Treatment group |
Primary outcome
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
1 secondary outcome
Activities Scale for Kids
Time frame: 8-9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
- Background: PubMed 19480872McGibbon 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.
- Background: PubMed 17057544Casady 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.
- Background: PubMed 14736353Benda 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.
- Background: PubMed 17558361Silkwood-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.
- Results publicationSilkwood-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]
- Derived from this study: PubMed 22247403Silkwood-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.
- Non profit organization that provides education, standards, terminology for physical, occupational and speech language pathologists using hippotherapy as part of their practice.Link provided by the sponsor.
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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.
Debbie J Silkwood-Sherer, PT, DHS principal investigator
Central Michigan University
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 Neuromuscular Diseases and Cerebral Palsy, run by Central Michigan University at 1 site in United States.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 11 Mar 2011. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (time frame: 8-9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313325, which also lists 6 linked publications.
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 11 Mar 2011.