Autism Spectrum Disorder Clinical Trial
— AUTISM-EATOfficial title:
Effectiveness of Equine Assisted Therapy in Children With Autism Spectrum Disorder: A Randomized Controlled Study
Verified date | September 2023 |
Source | Izmir Democracy University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | August 24, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 14 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Having hip or shoulder dislocation, osteoporosis/coxarthrosis, - Having uncontrollable seizures, - Having aneurysm, - Having a recent history of fracture, - Having decubitus, - Having atlantoaxial instability, - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Democracy University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Izmir Democracy University | Turkey Jockey Club Equine Therapy Center, Izmir, Turkey |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from baseline at 6 weeks | |
Primary | 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. | Change from baseline at 6 weeks | |
Primary | 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. | Change from baseline at 6 weeks | |
Primary | 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. | Change from baseline at 6 weeks |
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