Attention Deficit Hyperactivity DisorderNCT00717392
Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders
An observational study of Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. The purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Jul 2012
- Phase
- Observational
- 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
Study population: Hippotherapy subjects will be taken from horseback riding farms. Control subjects will be taken from a tertiary care clinic.
Who may be able to join
- Age: 5-17 years.
- A diagnosis of ADHD or ASD.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Ramat Gan
About this study
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. The purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy will show better outcomes than children with the same problems who are not treated with hippotherapy.
Read the detailed description
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. Most studies that tested hippotherapy were uncontrolled and focused on motor problems, such as cerebral palsy. Today, hippotherapy is used for various developmental problems such as Attention deficit / Hyperactivity disorder (ADHD) and Autism spectrum disorder (ASD), without clear information about its efficacy for these populations.
The purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy for 6 months will show better outcomes than children with the same problems who are not treated with hippotherapy.
Assessment:
- BRIEF questionnaire
- Stony Brook Questionnaire
All questionnaires will be applied at the beginning of the study and after 6 months.
- Keywords
- ADHD, ASD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy_ADHD | 10 children with ADHD who receive hippotherapy | |
| Hippotherapy_ASD | 10 children with ASD who receive hippotherapy | |
| Control_ADHD | 10 children with ADHD who DO NOT receive hippotherapy | |
| Control_ASD | 10 children with ASD who DO NOT receive hippotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the parameters of autism
Repetitive behaviors Eye contact Communication
Measured: Repetitive behaviors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Sheba 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Lidia Gabis MD, Sheba Medical Center
- Investigators
- Lidia Gabis, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717392
- Sponsor's protocol ID
- SHEBA-08-5327-LG-CTIL
- Status last verified
- Feb 2013
- First submitted
- 16 Jul 2008
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders
- ClinicalTrials.gov ID
- NCT00717392
- Acronym / sponsor ID
- SHEBA-08-5327-LG-CTIL
- Keywords
- ADHD, ASD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Jul 2008 (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.
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. The purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy will show better outcomes than children with the same problems who are not treated with hippotherapy.
Detailed description
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. Most studies that tested hippotherapy were uncontrolled and focused on motor problems, such as cerebral palsy. Today, hippotherapy is used for various developmental problems such as Attention deficit / Hyperactivity disorder (ADHD) and Autism spectrum disorder (ASD), without clear information about its efficacy for these populations.
The purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy for 6 months will show better outcomes than children with the same problems who are not treated with hippotherapy.
Assessment:
- BRIEF questionnaire
- Stony Brook Questionnaire
All questionnaires will be applied at the beginning of the study and after 6 months.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy_ADHD | – | –10 children with ADHD who receive hippotherapy |
| Hippotherapy_ASD | – | –10 children with ASD who receive hippotherapy |
| Control_ADHD | – | –10 children with ADHD who DO NOT receive hippotherapy |
| Control_ASD | – | –10 children with ASD who DO NOT receive hippotherapy |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hippotherapy subjects will be taken from horseback riding farms. Control subjects will be taken from a tertiary care clinic.
Key inclusion criteria (2 listed)
- Age: 5-17 years.
- A diagnosis of ADHD or ASD.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improving the parameters of autism
Time frame: Repetitive behaviors
Repetitive behaviors Eye contact Communication
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 1 Mar 2013.
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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.
Lidia Gabis, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by Sheba Medical Center at 1 site in Israel.
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 1 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 1 Mar 2013. 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 Israel. 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?
Improving the parameters of autism (time frame: Repetitive behaviors). 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 1 Mar 2013.