NCT06777186

Brief Summary

The aim of our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. The sample number determined by power analysis will be included in the study. Socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the individuals who voluntarily participated in the study will be obtained. The individuals participating in the study will be divided into two groups as individuals with normal motor development and individuals with autism spectrum disorder and the same assessment scales will be used. These assessment scales are TUG, 10 meter walking test, Vineland Adaptive Adaptation Scale, Bruininks-Oseretsky Motor Competence Test. According to the evaluation results, motor skills, functional balance, dual task and social adaptation skills of individuals with autism will be compared with individuals with normal motor development.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

December 15, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 10, 2025

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 10 meter walk test

    The dual task skills of the individuals will be evaluated by adding motor and cognitive tasks to the 10-meter walk test.

    At enrollment

Secondary Outcomes (3)

  • Functional Balance

    At enrollment

  • Social Adaptation Assessment

    At enrollment

  • Motor skills and proficiency

    At enrollment

Study Arms (2)

Autism Spectrum Disorder

Other: 10 meter walk testOther: Functional BalanceOther: Social Adaptation AssessmentOther: Motor skills and proficiency

Healthy Children

Other: 10 meter walk testOther: Functional BalanceOther: Social Adaptation AssessmentOther: Motor skills and proficiency

Interventions

The dual task skills of the individuals will be evaluated by adding motor and cognitive tasks to the 10-meter walk test. Tasks given to individuals Single motor task (comfortable walking): The individual is asked to walk at normal speed, the time is recorded Motor-motor dual task: Both hands carry a half-full water bottle, time is recorded Motor-cognitive dual task (mental) : counts backwards from 10 by 1, time is recorded Motor - cognitive dual task (memory) : The individual is asked to say 3 words that were previously spoken. The time is recorded.

Autism Spectrum DisorderHealthy Children

It will be assessed with the TUG test. The TUG measures the time it takes for an individual to get up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down again after a ready, go signal.

Autism Spectrum DisorderHealthy Children

Adaptive behavior will be assessed with the Vineland Adaptive Behavior Scales. It is a parent interview designed to assess functioning in daily life. \[35\]Specifically, adaptive behavior is assessed in four domains: Communication, Daily Living, Socialization and Motor skills. Vineland has reliability and current validity. It has been reported to be sensitive to the difficulties experienced by children with ASD

Autism Spectrum DisorderHealthy Children

The Bruininks-Oseretsky Motor Proficiency Test (BOT-2) assesses fine motor, hand coordination, body coordination, strength and agility between the ages of 4-21 years.There are 53 items in the BOT-2. In BOT-2, there are four motor domains including fine motor control, hand coordination, body coordination, strength and agility and a total of eight subtests related to these domains.

Autism Spectrum DisorderHealthy Children

Eligibility Criteria

Age4 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

G\*Power (version 3.1.9.4) package program was used for power analysis. Assuming that the effect size that could be obtained between the two groups would be large (f = 0.543 (EFFECT SIZE)), as a result of the power analysis, it was calculated that 80% power could be obtained at 90% confidence level (with a margin of error of 0.05) when at least 110 people were included in the study

You may qualify if:

  • Being diagnosed with ASD by a physician
  • Children are receiving education in a special education and rehabilitation center
  • No vision problems
  • Ability to receive and execute commands
  • No cognitive problems
  • No walking problems

You may not qualify if:

  • Individuals with concomitant secondary diseases
  • Individuals who have undergone surgery in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, Kırıkkale, 71450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderMotor DisordersSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Central Study Contacts

Alper Gürbüz, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, MASTER'S STUDENT

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

December 15, 2024

Primary Completion

May 15, 2025

Study Completion

November 25, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations