Brachial Plexus PalsyNCT05540730
Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis
An observational study of Brachial Plexus Palsy and Gait Disorders in Children, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Palsy, Gait Disorders in Children
- What is being tested?
- Gait Analysis
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2017to 1 Jul 2022
- Phase
- Observational
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with obstetric brachial plexus paralysis
Who may be able to join
- Between the ages of 7-15. No other disease
Who cannot join
- Having undergone surgery or botox intervention for orthopedic problems in the last 6 months.
- Having health problems in the unaffected extremity or adversely affecting general body health.
- The participant's parent has not signed the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. The inclusion criteria of the study were to be between the ages of 7-15, not have a history of surgery or botox in the last 6 months, and not have any other disease. Foot plantar pressures of all participants will be analyzed with a pedobarography device. For arm swing analysis, a video camera will be recorded during walking and arm flexion/extension angles will be measured with Kinovea software.
- Conditions
- Brachial Plexus Palsy, Gait Disorders in Children
- Being tested
- Gait Analysis
- Keywords
- Brachial Plexus Palsy, Gait Disorders in Children, Biomechanics, Gait Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait AnalysisDiagnostic test
Foot plantar pressure with pedobarography and arm swing with video camera will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Obstetric brachial plexus paralysis | Not described Receives: Diagnostic Test: Gait Analysis | |
| Control | Not described Receives: Diagnostic Test: Gait Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stance Time
stance time phase during walking
Measured: during gait analysis.
Secondary outcomes (3)
Step Length
Measured: during gait analysis.
Ground reaction force
Measured: during gait analysis.
Single limb support phase
Single limb support phase during walking
Measured: during gait analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start24 Jan 2017
- Primary completion1 May 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus PalsyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Yunus Özdemir, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540730
- Sponsor's protocol ID
- IstanbulMUH-DPTR-Yozdemir-0094
- Status last verified
- Apr 2025
- First submitted
- 12 Sep 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis
- ClinicalTrials.gov ID
- NCT05540730
- Acronym / sponsor ID
- IstanbulMUH-DPTR-Yozdemir-0094
- Conditions
- Brachial Plexus Palsy, Gait Disorders in Children
- Keywords
- Brachial Plexus Palsy, Gait Disorders in Children, Biomechanics, Gait Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 15 Sep 2022 (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 aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. The inclusion criteria of the study were to be between the ages of 7-15, not have a history of surgery or botox in the last 6 months, and not have any other disease. Foot plantar pressures of all participants will be analyzed with a pedobarography device. For arm swing analysis, a video camera will be recorded during walking and arm flexion/extension angles will be measured with Kinovea software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstetric brachial plexus paralysis | – | Diagnostic Test: Gait Analysis |
| Control | – | Diagnostic Test: Gait Analysis |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with obstetric brachial plexus paralysis
Key inclusion criteria (1 listed)
- Between the ages of 7-15. No other disease
Key exclusion criteria (3 listed)
- Having undergone surgery or botox intervention for orthopedic problems in the last 6 months.
- Having health problems in the unaffected extremity or adversely affecting general body health.
- The participant's parent has not signed the consent form.
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 |
|---|---|---|
| Gait AnalysisFoot plantar pressure with pedobarography and arm swing with video camera will be analyzed. | Diagnostic test | Control, Obstetric brachial plexus paralysis |
Primary outcome
Stance Time
Time frame: during gait analysis.
stance time phase during walking
3 secondary outcomes
Step Length
Time frame: during gait analysis.
Ground reaction force
Time frame: during gait analysis.
Single limb support phase
Time frame: during gait analysis.
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 4 May 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Brachial Plexus Palsy and Gait Disorders in Children, run by Istanbul Medipol University Hospital 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 3 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 4 May 2025. 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?
Stance Time (time frame: during gait analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2025.