Neurodevelopmental Treatment for Balance and Mobility in Children With Down Syndrome

NCT07653399 | Completed

• 1 other identifier: OÖA_OAS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Down Syndrome; Neurodevelopmental Treatment; Bobath Concept; Balance; Functional Independence; Mobility; Walking Capacity; Early Intervention; Motor Development

Outcome Measures

Primary Outcomes (1)

• Balance Performance

  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

Secondary Outcomes (4)

• Functional Mobility

  Baseline and 8 weeks

• Walking Capacity

  Baseline and 8 weeks

• Functional Independence

  Baseline and 8 weeks

• Gross Motor Function Level

  Baseline and 8 weeks

Study Arms (1)

Neurodevelopmental Treatment

EXPERIMENTAL

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.

Behavioral: Neurodevelopmental Treatment (NDT)

Interventions

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.

Neurodevelopmental Treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Nisantasi University: lead

Study Sites (1)

Tek Metod Special Education and Rehabilitation Center

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Tekin F, Kavlak E, Cavlak U, Altug F. Effectiveness of Neuro-Developmental Treatment (Bobath Concept) on postural control and balance in Cerebral Palsied children. J Back Musculoskelet Rehabil. 2018;31(2):397-403. doi: 10.3233/BMR-170813.

  PMID: 29171980 BACKGROUND

• Demir-Er Ş, Alkan H, Topuz S, et al. Gait and static balance analysis of children with Down syndrome and comparison with typically developing children. Int J Dev Disabil. Epub ahead of print 2025. DOI: 10.1080/20473869.2025.2496723.

  BACKGROUND

• Rodriguez-Grande EI, Buitrago-Lopez A, Torres-Narvaez MR, Serrano-Villar Y, Verdugo-Paiva F, Avila C. Therapeutic exercise to improve motor function among children with Down Syndrome aged 0 to 3 years: a systematic literature review and meta-analysis. Sci Rep. 2022 Jul 29;12(1):13051. doi: 10.1038/s41598-022-16332-x.

  PMID: 35906275 BACKGROUND

• Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.

  PMID: 32273655 BACKGROUND

• Jain PD, Nayak A, Karnad SD, Doctor KN. Gross motor dysfunction and balance impairments in children and adolescents with Down syndrome: a systematic review. Clin Exp Pediatr. 2022 Mar;65(3):142-149. doi: 10.3345/cep.2021.00479. Epub 2021 Jun 11.

  PMID: 34126707 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: October 5, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 20, 2019
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.
• Access Criteria: 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.

Locations

TU (1)