NCT07739693

Brief Summary

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in social communication and interaction, as well as impairments in physical function domains such as postural control, balance, coordination, and motor planning. This study is designed as a randomized controlled trial to determine the effects of hippotherapy, applied in addition to a special education program, on physical function, bladder-bowel symptoms, and social communication level in children with ASD.

Trial Health

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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Autism spectrum disorderHippotherapyPhysical functionPostural balanceBladder and bowel dysfunctionSocial communicationChildrenHand grip strengthTrunk control

Outcome Measures

Primary Outcomes (6)

  • Balance

    Balance will be assessed using the Pediatric Balance Scale, a 14-item scale evaluating sitting balance, standing balance, transfers, reaching, turning, and stepping activities. The total score ranges from 0 to 56, with higher scores indicating better balance performance. The scale will be administered by a physiotherapist.

    Baseline and at the end of the 8-week intervention

  • Trunk Control

    Trunk control will be assessed using the Trunk Control Measurement Scale. The total score ranges from 0 to 58, with higher scores indicating better trunk control. The assessment will be administered by a physiotherapist.

    Baseline and at the end of the 8-week intervention

  • Posture

    Postural alignment will be assessed using the New York Posture Rating Chart. The total score ranges from 13 to 65, with higher scores indicating better postural alignment. The assessment will be performed by a physiotherapist.

    Baseline and at the end of the 8-week intervention

  • Handgrip Strength

    Handgrip strength will be measured in kilograms using a hand dynamometer. Three measurements will be obtained for each hand, with a 1-minute rest period between measurements. The mean value of the three measurements will be used in the analysis. Higher values indicate greater handgrip strength.

    Baseline and at the end of the 8-week intervention

  • Bladder and Bowel Symptoms

    Bladder and bowel symptoms will be assessed using the Bladder and Bowel Dysfunction Questionnaire. The total score ranges from 0 to 52, with higher scores indicating greater symptom severity. The questionnaire will be completed by the child with parental assistance.

    Baseline and at the end of the 8-week intervention

  • Social Communication

    Social communication will be assessed using the Autism Social Skills Profile-Turkish Form. The scale consists of 45 items and includes three subscales: social reciprocity, social participation/avoidance, and detrimental social behaviors. Items are rated on a 4-point Likert scale. Higher total scores indicate better social skills. The questionnaire will be completed by the participant's parent.

    Baseline and at the end of the 8-week intervention

Study Arms (2)

Hippotherapy Group

EXPERIMENTAL
Other: Hippotherapy Program

Control Group

ACTIVE COMPARATOR
Other: Special Education Program

Interventions

Participants will receive 30-minute hippotherapy sessions once weekly for 8 weeks in addition to their ongoing special education program. The program will include exercises targeting balance, postural control, trunk stabilization, coordination, muscle strength, upper extremity function, and sensory processing.

Hippotherapy Group

Participants will continue their ongoing special education program throughout the 8-week study period. The program includes educational activities, speech and language therapy, occupational therapy, proprioceptive activities, and sensory-based interventions according to the individual needs of the child.

Control Group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with autism spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
  • Able to understand and follow basic verbal instructions. Able to stand independently for at least 30 seconds. Voluntary participation in the study and written informed consent obtained from a parent or legal guardian.

You may not qualify if:

  • Presence of an active infection. Bladder or bowel symptoms attributable to an organic condition, such as anorectal malformation or Hirschsprung disease.
  • Presence of another neurological or orthopedic condition that may affect participation or outcomes, such as cerebral palsy or hip dislocation.
  • Inability to attend the treatment program regularly. Receipt of hippotherapy within the previous 12 months. History of epilepsy or seizures. History of surgery involving the spine and/or abdominopelvic region within the previous 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderIntestinal DiseasesCommunication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersGastrointestinal DiseasesDigestive System DiseasesBehavior

Central Study Contacts

Seyda Toprak Celenay, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the current ethics approval and informed consent procedures do not include sharing data with external researchers. In addition, the study involves a vulnerable pediatric population. Only aggregated and de-identified study results will be reported.

Locations