NCT06057311

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 21, 2023

Last Update Submit

September 29, 2023

Conditions

Keywords

Equine-assisted therapyHippotherapyAutism spectrum disorderSleepBalanceActivities of daily livingQuality of life

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

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.

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.

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.

Other: Control

Interventions

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.

Also known as: HT
Hippotherapy Group

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.

Also known as: EAAT
Equine-Assisted Activities Therapy Group
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.

Control Group

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Inability to adapt to the therapy,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, 35290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Betul Taspinar, Prof. Dr.

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

December 24, 2019

Primary Completion

March 10, 2020

Study Completion

August 24, 2020

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations