Equine-Assisted TherapyAUTISM-EATNCT06057311
Equine Assisted Therapy in Autism Spectrum Disorder
A study testing Hippotherapy and Equine-Assisted Activities Therapy in people with Equine-Assisted Therapy and Autism Spectrum Disorder, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder that negatively affects social interaction, communication, and behavior. Various animals have started to be used for therapeutic purposes by those in need. In recent years, especially equine-assisted therapies have become popular. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Equine-Assisted Therapy, Autism Spectrum Disorder
- What is being tested?
- Hippotherapy and Equine-Assisted Activities Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2019to 24 Aug 2020
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with ASD,
- Having <60 kg in body weight
- Having no shunt,
- Having no allergy to feathers or dust,
- Having not previously received equine-assisted therapy.
Who cannot join
- Having hip or shoulder dislocation, osteoporosis/coxarthrosis,
- Having uncontrollable seizures,
- Having aneurysm,
- Having a recent history of fracture,
- Having decubitus,
- Having atlantoaxial instability,
Show all 20Show fewer
- Having hemophilia,
- Using anticoagulant drugs,
- Having acute arthritis,
- Having an unstable spine,
- Having acute disc hernia,
- Having spondylolisthesis,
- Having spinal fusion,
- Having no control of the head.
- Other exclusion criteria related to therapies;
- Inability to adapt to the therapy,
- Having a fear of horses,
- The occurrence of seizures or worsening of the existing seizure status,
- Worsening of vital signs,
- Requesting to quit the study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Equine Assisted Therapy in Children With Autism Spectrum Disorder: A Randomized Controlled Study
Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder that negatively affects social interaction, communication, and behavior. Various animals have started to be used for therapeutic purposes by those in need. In recent years, especially equine-assisted therapies have become popular. However, it has been reported in the literature that more studies on this subject are needed. Therefore, the aim of this study was to examine the effects of equine-assisted therapy for children with autism on daily living activities, balance, quality of life, and sleep.
Read the detailed description
Autism Spectrum Disorder (ASD) was first defined by Leo Kanner in 1943 as a common neurodevelopmental disorder that has a negative effect on social interaction, communication, and behaviour. These individuals have problems such as impaired sensory processing skills, reduced balance and coordination, difficulties in undertaking daily living activities, diminished quality of life, sleep problems, and poor speech and language skills. According to the 2015 report published by the American National Autism Center, treatments are examined under three headings: those based on science, those promising, and those not based on science. Animal support therapies are included in the intervention not based on science.
It can be seen in the literature that the relationship between people and animals provides people with physical, mental and psychological support. Because of the positive effects of this relationship, various animals have started to be used for therapeutic purposes by those in need. Horses are used most often because accessibility is easy and they share many characteristics with humans. Therapies that include horses come under the following five headings: Adaptive Riding, Equine Assisted Activities, Equine Assisted Psychotherapy, Equine Assisted Therapy, and Hippotherapy.
Equine-assisted therapy is used in several pathologies and various age groups, most commonly in pediatric rehabilitation. However, there are few studies in the literature on this subject. Therefore, the aim of this study was to examine the effects of equine-assisted therapy for children with autism on daily living activities, balance, quality of life, and sleep. Thus, it is thought to contribute to the literature in terms of the effectiveness of applying equine-assisted therapies together with traditional therapies in individuals with autism spectrum disorder.
Study Hypothesis as follows: Equine-Assisted Therapies have an effect on daily living activities, balance, quality of life, and sleep of individuals with ASD.
- Conditions
- Equine-Assisted Therapy, Autism Spectrum Disorder
- Being tested
- Hippotherapy, Equine-Assisted Activities Therapy, Control
- Keywords
- Equine-assisted therapy, Hippotherapy, Autism spectrum disorder, Sleep, Balance, Activities of daily living, Quality of life
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Also called HT
The participants in HT Group; received 12 sessions as 2 sessions a week for 6 weeks. Each therapy session lasted for an average of 20 min. The assessments were applied twice to all participants before and after the training. The treatments and assessments were performed by the same physiotherapist in the same environment.
Equine-Assisted Activities TherapyOther
Also called EAAT
The participants in the EAAT Group received 12 sessions as 2 sessions a week for 6 weeks. Each therapy session lasted for an average of 20 min. The assessments were applied twice to all participants before and after the training. The treatments and assessments were performed by the same physiotherapist in the same environment.
ControlOther
The Control Group (CG) did not receive any training. The assessments were applied twice to CG at baseline and after 6 weeks. The treatments and assessments were performed by the same physiotherapist in the same environment.
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy Group | Experimental | The sessions for the HTG were conducted on horseback by a "leader", "side walker", and "physiotherapist" while the child was mounted on the horse. Before mounting, the child was dressed in the safety equipment of a helmet and rider vest by the physiotherapist and was directed to mount the horse from the mounting steps. In the first week of training, the cases received adaptation training. Within the training, 7 min of simple sitting on the horse were performed. In this position, the child was able to caress the horse's neck with one or both hands, rest while the horse walked, and 10 standing (or for those who could not do this, the horse was in a standing position)n the stirrups exercises were performed while holding the retaining strap. Receives: Other: Hippotherapy |
| Equine-Assisted Activities Therapy Group | Experimental | Under the guidance of the physiotherapist, the children in the EAATG performed routine care of the horse, such as grooming, feeding, and hoof care. During equine-assisted activities, the physiotherapist ensured the correct positioning of the child's body when approaching the horse using equipment and during movement. The study participants groomed the horse, wiped the horse's feathers with a towel, combed the mane, checked the hooves, cleaned out any grit, and performed the procedures for the horse to go out. Finally, the child gave food and water to the horse, said farewell and left the therapy area. Receives: Other: Equine-Assisted Activities Therapy |
| Control Group | Other | The children in the control group were evaluated at the same time as the other groups but were not included in any therapy. All assessments were conducted at baseline and 6 weeks later. When the study was completed, the subjects in this group were permitted 10 sessions of hippotherapy if they so wished. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Activities of Daily Living
Activities of daily living (ADL) were evaluated with the Waisman Activities of Daily Living Scale (W-ADLS), for which validity and reliability studies were conducted in Turkey in 2016. The scale consists of 17 items scored from 0 (cannot do this at all) to 2 (can do this independently). The scale has higher points showing independence.
Measured: Change from baseline at 6 weeks
The Assessment of Balance
The Paediatric Balance Scale (PBS) developed by Franjoine was used to evaluate balance. Validity and reliability studies of the scale in Turkish were conducted by Karali. The scale consists of 14 items evaluating daily activities of the child at home, school, and in the community. Each item is scored from 0 (the activity cannon be performed independently) to 4 (the activity is performed independently) giving a total score in the range of 0 - 56. Higher points indicate good balance.
Measured: Change from baseline at 6 weeks
Assessment of Quality of Life
The original German healthy quality of life questionnaire (KINDL) was tested for validity and reliability in Turkish by Eser et al. in 2008. There are family forms (Kiddy Kindl Parents and Kid and Kiddo Kindl Parents) for children in the age ranges of 4 - 7 years and 8 - 12 years, who will not be able to complete the form. The family form of this questionnaire was used in this study. Total points range from 0 to 100, with higher points showing a good quality of life.
Measured: Change from baseline at 6 weeks
Assessment of Sleep Habits
The sleep habits of the participants were evaluated using the short Turkish version of the Children's Sleep Habits Questionnaire (CSHQ), which was developed to assess the sleep habits and problems of children. The questionnaire consists of 33 items. The total score of the items is seen as 41 lines, and as the score increases, sleep habits change at a better rate. Turkish validity and reliability studies were conducted by Fis et al. in 2010.
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start24 Dec 2019
- Primary completion10 Mar 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equine-Assisted TherapyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkey Jockey Club Equine Therapy Center, Izmir, Turkey
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Betul Taspinar, Prof. Dr., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057311
- Sponsor's protocol ID
- AUTISM-EAT-35
- Acronym
- AUTISM-EAT
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Equine Assisted Therapy in Children With Autism Spectrum Disorder: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06057311
- Acronym / sponsor ID
- AUTISM-EAT / AUTISM-EAT-35
- Conditions
- Equine-Assisted Therapy, Autism Spectrum Disorder
- Keywords
- Equine-assisted therapy, Hippotherapy, Autism spectrum disorder, Sleep, Balance, Activities of daily living, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Collaborators
- Turkey Jockey Club Equine Therapy Center, Izmir, Turkey
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 28 Sep 2023 (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.
Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder that negatively affects social interaction, communication, and behavior. Various animals have started to be used for therapeutic purposes by those in need. In recent years, especially equine-assisted therapies have become popular. However, it has been reported in the literature that more studies on this subject are needed. Therefore, the aim of this study was to examine the effects of equine-assisted therapy for children with autism on daily living activities, balance, quality of life, and sleep.
Detailed description
Autism Spectrum Disorder (ASD) was first defined by Leo Kanner in 1943 as a common neurodevelopmental disorder that has a negative effect on social interaction, communication, and behaviour. These individuals have problems such as impaired sensory processing skills, reduced balance and coordination, difficulties in undertaking daily living activities, diminished quality of life, sleep problems, and poor speech and language skills. According to the 2015 report published by the American National Autism Center, treatments are examined under three headings: those based on science, those promising, and those not based on science. Animal support therapies are included in the intervention not based on science.
It can be seen in the literature that the relationship between people and animals provides people with physical, mental and psychological support. Because of the positive effects of this relationship, various animals have started to be used for therapeutic purposes by those in need. Horses are used most often because accessibility is easy and they share many characteristics with humans. Therapies that include horses come under the following five headings: Adaptive Riding, Equine Assisted Activities, Equine Assisted Psychotherapy, Equine Assisted Therapy, and Hippotherapy.
Equine-assisted therapy is used in several pathologies and various age groups, most commonly in pediatric rehabilitation. However, there are few studies in the literature on this subject. Therefore, the aim of this study was to examine the effects of equine-assisted therapy for children with autism on daily living activities, balance, quality of life, and sleep. Thus, it is thought to contribute to the literature in terms of the effectiveness of applying equine-assisted therapies together with traditional therapies in individuals with autism spectrum disorder.
Study Hypothesis as follows: Equine-Assisted Therapies have an effect on daily living activities, balance, quality of life, and sleep of individuals with ASD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy Group | Experimental | Other: HippotherapyThe sessions for the HTG were conducted on horseback by a "leader", "side walker", and "physiotherapist" while the child was mounted on the horse. Before mounting, the child was dressed in the safety equipment of a helmet and rider vest by the physiotherapist and was directed to mount the horse from the mounting steps. In the first week of training, the cases received adaptation training. Within the training, 7 min of simple sitting on the horse were performed. In this position, the child was able to caress the horse's neck with one or both hands, rest while the horse walked, and 10 standing (or for those who could not do this, the horse was in a standing position)n the stirrups exercises were performed while holding the retaining strap. |
| Equine-Assisted Activities Therapy Group | Experimental | Other: Equine-Assisted Activities TherapyUnder the guidance of the physiotherapist, the children in the EAATG performed routine care of the horse, such as grooming, feeding, and hoof care. During equine-assisted activities, the physiotherapist ensured the correct positioning of the child's body when approaching the horse using equipment and during movement. The study participants groomed the horse, wiped the horse's feathers with a towel, combed the mane, checked the hooves, cleaned out any grit, and performed the procedures for the horse to go out. Finally, the child gave food and water to the horse, said farewell and left the therapy area. |
| Control Group | Other | Other: ControlThe children in the control group were evaluated at the same time as the other groups but were not included in any therapy. All assessments were conducted at baseline and 6 weeks later. When the study was completed, the subjects in this group were permitted 10 sessions of hippotherapy if they so wished. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with ASD,
- Having <60 kg in body weight
- Having no shunt,
- Having no allergy to feathers or dust,
- Having not previously received equine-assisted therapy.
Key exclusion criteria (20 listed)
- Having hip or shoulder dislocation, osteoporosis/coxarthrosis,
- Having uncontrollable seizures,
- Having aneurysm,
- Having a recent history of fracture,
- Having decubitus,
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 |
|---|---|---|
| HippotherapyAlso: HTThe participants in HT Group; received 12 sessions as 2 sessions a week for 6 weeks. Each therapy session lasted for an average of 20 min. The assessments were applied twice to all participants before and after the training. The treatments and assessments were performed by the same physiotherapist in the same environment. | Other | Hippotherapy Group |
| Equine-Assisted Activities TherapyAlso: EAATThe participants in the EAAT Group received 12 sessions as 2 sessions a week for 6 weeks. Each therapy session lasted for an average of 20 min. The assessments were applied twice to all participants before and after the training. The treatments and assessments were performed by the same physiotherapist in the same environment. | Other | Equine-Assisted Activities Therapy Group |
| ControlThe Control Group (CG) did not receive any training. The assessments were applied twice to CG at baseline and after 6 weeks. The treatments and assessments were performed by the same physiotherapist in the same environment. | Other | Control Group |
Primary outcome
Assessment of Activities of Daily Living
Time frame: Change from baseline at 6 weeks
Activities of daily living (ADL) were evaluated with the Waisman Activities of Daily Living Scale (W-ADLS), for which validity and reliability studies were conducted in Turkey in 2016. The scale consists of 17 items scored from 0 (cannot do this at all) to 2 (can do this independently). The scale has higher points showing independence.
The Assessment of Balance
Time frame: Change from baseline at 6 weeks
The Paediatric Balance Scale (PBS) developed by Franjoine was used to evaluate balance. Validity and reliability studies of the scale in Turkish were conducted by Karali. The scale consists of 14 items evaluating daily activities of the child at home, school, and in the community. Each item is scored from 0 (the activity cannon be performed independently) to 4 (the activity is performed independently) giving a total score in the range of 0 - 56. Higher points indicate good balance.
Assessment of Quality of Life
Time frame: Change from baseline at 6 weeks
The original German healthy quality of life questionnaire (KINDL) was tested for validity and reliability in Turkish by Eser et al. in 2008. There are family forms (Kiddy Kindl Parents and Kid and Kiddo Kindl Parents) for children in the age ranges of 4 - 7 years and 8 - 12 years, who will not be able to complete the form. The family form of this questionnaire was used in this study. Total points range from 0 to 100, with higher points showing a good quality of life.
Assessment of Sleep Habits
Time frame: Change from baseline at 6 weeks
The sleep habits of the participants were evaluated using the short Turkish version of the Children's Sleep Habits Questionnaire (CSHQ), which was developed to assess the sleep habits and problems of children. The questionnaire consists of 33 items. The total score of the items is seen as 41 lines, and as the score increases, sleep habits change at a better rate. Turkish validity and reliability studies were conducted by Fis et al. in 2010.
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 2 Oct 2023.
- 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.
Betul Taspinar, Prof. Dr. principal investigator
Izmir Democracy 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 and Equine-Assisted Activities Therapy in people with Equine-Assisted Therapy and Autism Spectrum Disorder, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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 5 inclusion and 20 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 2 Oct 2023. 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 Turkey (Türkiye). 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?
Assessment of Activities of Daily Living (time frame: Change from baseline at 6 weeks). The study lists 4 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 2 Oct 2023.