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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06057311
Other study ID # AUTISM-EAT-35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 24, 2019
Est. completion date August 24, 2020

Study information

Verified date September 2023
Source Izmir Democracy University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hippotherapy
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 Therapy
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.
Control
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.

Locations

Country Name City State
Turkey Izmir Democracy University Izmir

Sponsors (2)

Lead Sponsor Collaborator
Izmir Democracy University Turkey Jockey Club Equine Therapy Center, Izmir, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

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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