Down Syndrome
Conditions
Keywords
Down Syndrome, Neurodevelopmental Treatment, Bobath Concept, Balance, Functional Independence, Mobility, Walking Capacity, Early Intervention, Motor Development
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALNeurodevelopmental Treatment (NDT)
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.
Sponsors
Istanbul Nisantasi University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance Performance | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Mobility | 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. |
| Walking Capacity | 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. |
| Functional Independence | 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. |
| Gross Motor Function Level | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed