NCT06766942

Brief Summary

The aim of this study was to investigate the effects of the Structured Sherborne Developmental Movement Program on sensory processing, motor performance and functional status in children with autism spectrum disorders.

Trial Health

87
On Track

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
Completed

Started Sep 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 4, 2025

Last Update Submit

March 16, 2026

Conditions

Keywords

autism spectrum disordermotor activitymovement

Outcome Measures

Primary Outcomes (2)

  • Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2)

    It was developed by Robert H. Bruininks and Brett D. Bruininks in 2005. It is a performance-based test that can be applied individually using engaging and targeted activities to evaluate a wide range of motor skills in individuals between the ages of 4-21. BOT-2 can be used for 5 different purposes, including supporting motor disorder diagnoses, screening, making placement decisions, evaluating and developing motor training programs, and conducting scientific research. BOT-2 consists of 4 sections: Fine Hand Control, Hand Coordination, Body Coordination, Strength, and Agility. Each section consists of two subtests and contains a total of 53 items. The total score to be obtained from the short form of BOT-2 is at least 0 and at most 88. It can be interpreted that motor performance increases as the score obtained from the short form increases.

    3 months

  • Dunn Sensory Profile

    The Dunn Sensory Profile, developed by Winnie Dunn in 1999, is a self-reported questionnaire that can measure children's sensory processing abilities and reveal the effects of sensory processing on children's functional performance in their daily lives, and can determine children's sensory performance in detail. The questionnaire can be applied to children with different types and degrees of disability. The assessment is carried out by rating the items in the questionnaire according to their frequency by the mother, father or caregiver; that is, the persons who are primarily responsible for the child's care. The questionnaire consists of 3 main sections, which are also divided into groups, and a total of 125 items.

    3 months

Secondary Outcomes (7)

  • Gilliam Autistic Rating Scale-2 (GARS-2)

    3 months

  • Autism Social Skills Profile

    3 months

  • Repetitive behaviors scale - revised - turkish version (TEDÖ-R-TV)

    3 months

  • Children's Sleep Habits Questionnaire (CSHQ)

    3 months

  • Quality of Life Scale for Children

    3 months

  • +2 more secondary outcomes

Study Arms (3)

the structured Sherborne developmental movement and sensory-based occupational therapy group

EXPERIMENTAL

The structured Sherborne developmental movement and sensory-based occupational therapy are implemented together.

Other: structured sherborne developmental movement program with sensory-based occupational therapy program

the group to which the sensory-based occupational therapy program was applied

EXPERIMENTAL

only sensory-based occupational therapy program is applied.

Other: sensory-based occupational therapy program group

control group

OTHER

Structured Sherborne developmental movement and sensory-based occupational therapy programs are not implemented.

Other: control group

Interventions

This group will not participate in any activities outside of the standard special education program.

control group

In addition to the sensory-based occupational therapy they receive at the rehabilitation center for 45 minutes, two days a week for 12 weeks, the Structured Sherborne Developmental Movement Program will be applied.

the structured Sherborne developmental movement and sensory-based occupational therapy group

Sensory-based occupational therapy programmed according to the individual's needs and disabilities will be applied to this group by an occupational therapist at the rehabilitation center for 45 minutes, 2 days a week for 12 weeks.

the group to which the sensory-based occupational therapy program was applied

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 8-12 Being diagnosed with autism spectrum disorder (ASD) Having the Family Consent Form approved by the child's primary caregiver Having the necessary prerequisite skills to participate in the study
  • Being able to follow the commands given,
  • Being able to imitate the model by taking the cues as a model,
  • Having no other physical or mental disability other than ASD,
  • Having no other health problems,
  • Having the ability to hold the toilet.

You may not qualify if:

  • Participant participating in an education and therapy program without the researcher's knowledge during the study Having problems adapting to the evaluation and education program Participant wanting to leave the study for any reason during the research process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sariçam, 01250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • ELİF D ATILGAN

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: An experimental study with 3 groups and a control group in which the effects of two independent variables were examined.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 9, 2025

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 20, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations