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Neurodevelopmental Treatment for Balance and Mobility in Children With Down Syndrome

2026년 6월 12일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

중재적

등록 (실제)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Balance Performance
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Mobility
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 10월 5일

기본 완료 (실제)

2019년 12월 5일

연구 완료 (실제)

2019년 12월 20일

연구 등록 날짜

최초 제출

2026년 6월 12일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다운 증후군에 대한 임상 시험

Neurodevelopmental Treatment (NDT)에 대한 임상 시험

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