Down SyndromeNCT07653399
Neurodevelopmental Treatment for Balance and Mobility in Children With Down Syndrome
A study testing Neurodevelopmental Treatment (NDT) in people with Down Syndrome, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Neurodevelopmental Treatment (NDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tek Metod Special Education and Rehabilitation Center
Istanbul
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Neurodevelopmental Treatment (NDT)
- Keywords
- Down Syndrome, Neurodevelopmental Treatment, Bobath Concept, Balance, Functional Independence, Mobility, Walking Capacity, Early Intervention, Motor Development
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental Treatment (NDT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Neurodevelopmental Treatment (NDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (4)
Functional Mobility
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.
Measured: Baseline and 8 weeks
Walking Capacity
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.
Measured: Baseline and 8 weeks
Functional Independence
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.
Measured: Baseline and 8 weeks
Gross Motor Function Level
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start5 Oct 2019
- Primary completion5 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Atakan Sekibağ, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653399
- Sponsor's protocol ID
- OÖA_OAS
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29171980Demir-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.
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.
PubMed 35906275Zago 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.
PubMed 32273655Jain 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.
PubMed 34126707
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurodevelopmental Treatment on Balance, Mobility, Walking Capacity, and Functional Independence in Children With Down Syndrome: A Pilot Pre-Post Intervention Study
- ClinicalTrials.gov ID
- NCT07653399
- Acronym / sponsor ID
- OÖA_OAS
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Neurodevelopmental Treatment, Bobath Concept, Balance, Functional Independence, Mobility, Walking Capacity, Early Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental Treatment | Experimental | Behavioral: Neurodevelopmental Treatment (NDT)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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Neurodevelopmental Treatment |
Primary outcome
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.
4 secondary outcomes
Functional Mobility
Time frame: Baseline and 8 weeks
Walking Capacity
Time frame: Baseline and 8 weeks
Functional Independence
Time frame: Baseline and 8 weeks
Gross Motor Function Level
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 29171980Tekin 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.
- BackgroundDemir-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: PubMed 35906275Rodriguez-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.
- Background: PubMed 32273655Zago 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.
- Background: PubMed 34126707Jain 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.
- Individual participant dataSharing planned: Yes. 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.
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Treatment (NDT) in people with Down Syndrome, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Performance (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07653399, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.