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Completed

NCT Number: NCT07653399

Neurodevelopmental Treatment for Balance and Mobility in Children With Down Syndrome

The goal of this clinical trial is to evaluate whether Neurodevelopmental Treatment (NDT) can improve balance, mobility, walking capacity, and functional independence in preschool children with Down syndrome.

The main questions it aims to answer are:

* Does an 8-week Neurodevelopmental Treatment program improve balance performance in children with Down syndrome? * Does Neurodevelopmental Treatment improve mobility, walking capacity, functional independence, and gross motor function in children with Down syndrome? * Are baseline balance performance and age of independent standing associated with treatment-related balance improvements?

All participants will receive individualized Neurodevelopmental Treatment based on the Bobath concept twice weekly for 8 weeks.

Participants will:

* Undergo baseline assessments of balance, mobility, walking capacity, functional independence, and gross motor function * Participate in individualized Neurodevelopmental Treatment sessions twice weekly for 8 weeks * Complete the same outcome assessments following the intervention period

The findings may help improve understanding of rehabilitation outcomes and factors associated with treatment responsiveness in children with Down syndrome.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tek Metod Special Education and Rehabilitation Center

Istanbul, Turkey (Türkiye)

About this study

Down syndrome (DS) is one of the most common genetic conditions associated with intellectual disability and is frequently accompanied by motor impairments, including hypotonia, ligamentous laxity, delayed motor development, impaired balance, and reduced functional mobility. These impairments may negatively affect participation in daily activities and functional independence during childhood.

Neurodevelopmental Treatment (NDT), also known as the Bobath concept, is widely used in pediatric rehabilitation to facilitate postural control, movement quality, sensory-motor integration, and functional performance. Although NDT is commonly applied in clinical practice, evidence regarding its effects on balance, mobility, walking capacity, and functional independence in children with Down syndrome remains limited.

This pilot study was designed to investigate changes in motor and functional outcomes following an individualized 8-week NDT program in preschool children with Down syndrome. In addition to evaluating intervention-related changes, the study explored whether baseline balance performance and age of independent standing were associated with treatment responsiveness. Understanding factors that may influence rehabilitation outcomes could support more individualized treatment planning and improve clinical decision-making in pediatric rehabilitation.

The findings of this study are expected to provide preliminary evidence regarding the potential role of NDT in improving functional outcomes in children with Down syndrome and to inform the design of future controlled rehabilitation trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of Down syndrome Age between 3 and 6 years Gross Motor Function Classification System (GMFCS) Level I or II Ability to walk independently without assistive devices Ability to cooperate with assessment and treatment procedures Parent or legal guardian willing to provide informed consent

Exclusion criteria

Severe visual impairment Diagnosis of autism spectrum disorder Significant cooperation difficulties preventing participation in assessments or treatment Failure to regularly attend the physiotherapy program Lower-extremity surgery within the previous 6 months Any medical condition that would prevent safe participation in the intervention program

Treatment and study plan

Neurodevelopmental Treatment (NDT)

Behavioral

Neurodevelopmental Treatment (NDT) based on the Bobath concept was delivered individually twice weekly for 8 weeks. Treatment sessions focused on improving postural control, balance, mobility, motor performance, and functional independence through task-oriented activities, therapist facilitation techniques, and sensory-motor stimulation. Intervention content was individualized according to each participant's motor abilities and functional needs.

Primary outcomes

  1. Balance Performance

    Time frame: Baseline and 8 weeks

    Balance performance assessed using the Pediatric Balance Scale (PBS). The PBS consists of 14 items scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance performance.

Secondary outcomes

  1. Functional Mobility

    Time frame: Baseline and 8 weeks

    Functional mobility assessed using the Modified Timed Up and Go Test (mTUG). The time required to complete the test is recorded in seconds. Lower completion times indicate better functional mobility.

  2. Walking Capacity

    Time frame: Baseline and 8 weeks

    Walking capacity assessed using the One-Minute Walk Test (1MWT). Total walking distance covered in one minute is recorded in meters. Greater walking distance indicates better walking capacity.

  3. Functional Independence

    Time frame: Baseline and 8 weeks

    Functional independence assessed using the Pediatric Functional Independence Measure (WeeFIM). The WeeFIM contains 18 items scored on a 7-point scale, yielding a total score ranging from 18 to 126. Higher scores indicate greater functional independence.

  4. Gross Motor Function Level

    Time frame: Baseline and 8 weeks

    Gross motor function level assessed using the Gross Motor Function Classification System (GMFCS). The GMFCS classifies motor function into five levels (Level I-V), with Level I representing the highest level of motor function and Level V representing the lowest level of motor function.

Sponsors and collaborators

Lead sponsor

Istanbul Nisantasi University

Other

Registry information

Official study title

Effects of Neurodevelopmental Treatment on Balance, Mobility, Walking Capacity, and Functional Independence in Children With Down Syndrome: A Pilot Pre-Post Intervention Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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