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Neurodevelopmental Treatment for Balance and Mobility in Children With Down Syndrome

12. juni 2026 opdateret af: Onur Atakan Sekibağ, Istanbul Nisantasi University

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye)
        • Tek Metod Special Education and Rehabilitation Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Neurodevelopmental Treatment
Participants received individualized Neurodevelopmental Treatment (NDT) based on the Bobath concept twice weekly for 8 weeks. Each treatment session lasted approximately 55-60 minutes and included balance training, postural control exercises, weight-shifting activities, gait training, trunk control exercises, functional reaching activities, stair negotiation practice, and task-oriented functional activities tailored to each child's abilities and needs.
Adfærdsmæssigt: Neurodevelopmental 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Balance Performance
Tidsramme: 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.
Baseline and 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Mobility
Tidsramme: 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.
Baseline and 8 weeks
Walking Capacity
Tidsramme: 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.
Baseline and 8 weeks
Functional Independence
Tidsramme: 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.
Baseline and 8 weeks
Gross Motor Function Level
Tidsramme: 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.
Baseline and 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul Nisantasi University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. oktober 2019

Primær færdiggørelse (Faktiske)

5. december 2019

Studieafslutning (Faktiske)

20. december 2019

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OÖA_OAS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, outcome measure scores, and derived variables used in the analyses, will be made available to qualified researchers upon reasonable request.

IPD-delingstidsramme

Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.

IPD-delingsadgangskriterier

Access will be granted to researchers whose proposed use of the data has been approved by the study investigators. Requests should include a methodologically sound research proposal. De-identified participant-level data, the study protocol, and statistical analysis plan will be provided for non-commercial scientific research purposes. Data will be shared through direct contact with the corresponding author and subject to a data-sharing agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Downs syndrom

Kliniske forsøg med Neurodevelopmental Treatment (NDT)

Søg i lignende forsøg

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Medicinske tilstande

Narkotikainterventioner

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Betingelser

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