NCT06977256

Brief Summary

This randomized controlled trial aimed to compare the effects of a traditional sensory-based intervention and a telerehabilitation-based sensory intervention in children aged 3-7 years diagnosed with Developmental Coordination Disorder (DCD). Participants were randomly assigned to either face-to-face or combined face-to-face and telerehabilitation groups. The outcome measures included occupational performance, sensory processing, and functional independence. The study was conducted with ethical approval, and informed consent was obtained from all legal guardians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

Study Start

First participant enrolled

July 20, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

May 9, 2025

Last Update Submit

June 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Canadian Occupational Performance Measure (COPM)

    The Canadian Occupational Performance Measure (COPM) is a standardized assessment tool frequently used by occupational therapists to identify problems in occupational performance areas and to measure individuals' perceived performance and satisfaction levels. The COPM is administered through a semi-structured interview and takes approximately 20-30 minutes to complete. It involves individuals rating their performance and satisfaction in the areas of self-care, productivity, and leisure activities. The COPM has been adapted and validated across various age groups and diagnostic populations and is commonly used in pediatric settings as well.

    From enrollment to the end of treatment at 8 weeks

  • Dunn Sensory Profile

    In this study, the Parent Questionnaire version of the Sensory Profile was administered to assess the sensory processing patterns of participating children. Developed by Winnie Dunn in 1999, the Sensory Profile is designed for children aged 3 to 10 and consists of 125 items evaluating various aspects of sensory development. The tool identifies four sensory response patterns: sensitivity, registration, avoidance, and seeking. Scoring is categorized into three main domains: sensory processing, modulation, and behavioral/emotional responses. The questionnaire includes subscales such as auditory, visual, vestibular, tactile, multisensory, and oral sensory processing, as well as items addressing endurance, posture, activity level, emotional modulation, and social-emotional responses.

    From enrollment to the end of treatment at 8 weeks

  • Functional Independence Measure for Children (WeeFIM)

    The Functional Independence Measure for Children (WeeFIM) was developed to address the sensitivity and comprehensiveness limitations of the Barthel Index in assessing functional independence. It evaluates both motor and cognitive components of a child's functional abilities and is based on the International Classification of Functioning, Disability and Health (ICF). The WeeFIM consists of 18 items, divided into two domains: 13 items in the motor domain and 5 items in the cognitive domain. It is commonly used to assess the level of assistance required by children in daily activities.

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Sensory-Based Intervention Group

ACTIVE COMPARATOR

For the Sensory-Based Intervention Group, participants received a 40-minute face-to-face session once a week for 8 weeks, consisting of structured exercise and sensory-based interventions. Sessions were conducted in a therapy room equipped with sensory and activity materials. At the end of each session, caregivers were provided with feedback, their questions were addressed, and individualized home assignments were given. The intervention program for each child was tailored to their individual needs, and the progression of activities was personalized and adjusted based on each child's performance and development throughout the study.

Other: Sensory-Based Exercises

Telerehabilitation-Based Sensory Intervention Group

EXPERIMENTAL

For the Telerehabilitation-Based Sensory Intervention Group, participants received 40-minute in-person sensory-based sessions once a week for 8 weeks, followed by 30-minute telerehabilitation sessions once a week for an additional 8 weeks. Telerehabilitation was delivered via Zoom using a webcam-equipped computer. The online sessions were designed as a continuation of the face-to-face intervention and included individualized activity plans, caregiver coaching, home program recommendations, and ergonomic adjustments. Caregivers were informed in advance about required materials and setup. Each session was adapted to the child's developmental level, with activities progressively structured from simple to complex.

Other: Sensory-Based ExercisesOther: Telerehabilitation and Based Sensory Intervention

Interventions

Participants in the Sensory-Based Intervention Group received weekly 40-minute face-to-face sessions for 8 weeks, involving structured exercise and sensory-based activities tailored to individual needs, with caregiver feedback and home programs provided after each session.

Sensory-Based Intervention GroupTelerehabilitation-Based Sensory Intervention Group

Participants in the Telerehabilitation-Based Sensory Intervention Group received 8 weeks of in-person sessions followed by 8 weeks of weekly 30-minute telerehabilitation sessions, combining individualized sensory-based activities with caregiver coaching and home-based implementation via Zoom. Sessions were personalized, progressively structured, and conducted in a stable virtual environment to support continuity and engagement.

Telerehabilitation-Based Sensory Intervention Group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having a neurodevelopmental disorder with a confirmed diagnosis of one of the following: autism spectrum disorder, intellectual disability, developmental delay, communication disorder, or attention deficit hyperactivity disorder (ADHD)
  • Absence of any condition that may interfere with cooperation during the study
  • Receiving occupational therapy training for a duration between 3 months and 1 year to ensure group homogeneity in terms of prior therapy experience

You may not qualify if:

  • Presence of any visual or hearing impairment that could affect study outcomes
  • Having any systemic disease
  • Having a physical disability that may interfere with movement or motor function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Günışığı Counseling Center and Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

Related Publications (1)

  • Uruc M, Menek B. The effect of telerehabilitation on activity performance and participation in daily life in children with developmental coordination disorder: A randomized controlled trial. PLoS One. 2025 Aug 21;20(8):e0330846. doi: 10.1371/journal.pone.0330846. eCollection 2025.

MeSH Terms

Conditions

Motor Skills DisordersMotor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mazlum Uruc, MSc

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 18, 2025

Study Start

July 20, 2023

Primary Completion

December 5, 2024

Study Completion

December 20, 2024

Last Updated

June 3, 2025

Record last verified: 2025-06

Locations