Gait Disorders in ChildrenNCT06142721
Comparison of Walking Parameters Between Idiopathic Toe Walking and Independent Walking Diparetic Cerebral Palsy
An observational study of Gait Disorders in Children and Cerebral Palsy Spastic Diplegia, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders in Children, Cerebral Palsy Spastic Diplegia
- What is being tested?
- 3D Gait Analysis
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 15 Jan 2023
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A total of 51 cases, including 17 ITW(female:4;male:13), 15 DCP(female:5;male:10) and 19 Control groups (female:6;male:13), were included.
Who may be able to join
- Voluntary consent from family
- Diagnosed with idiopathic toe walking and spastic diparesis between the ages of 3-18.
- Cases with GMFCS 1
- The patients who applied to the healthy children's clinic, showed typical development, did not have any musculoskeletal and neurological problems, and wished to voluntarily participate in the study were included in the control group.
Who cannot join
- Refusing to participate in the study
- Under the age of 3 and over the age of 18
- Not at GMFCS 1 level
- Cases who did not have any orthopedic problems other than accompanying toe walking were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Walking Parameters Between Idiopathic Toe Walking Children and Children With Independent Walking Diparetic Cerebral Palsy
The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital.
Read the detailed description
It is an observational study. The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital. 51 cases will be included in our study. These cases will be divided into three groups. The first group will consist of patients diagnosed with idioaptic toe walking (n:17), the second group will be composed of diparetic cerebral palsy (n:15) with independent ambulation, and the third group will be the control group (n:19). First, the demographic information of the cases will be recorded. With 3D walking analysis, kinetic, kinematic and static data will be collected. The analysis of the obtained data will be done with Polygon Software (Vicon, Oxford, UK). Evaluated kinetic, kinematic and static parameters will be compared between three groups.
Is the lower extremity compensation of children with diparetic cerebral palsy who can walk independently more than children with idiopathic toe walking?
- Being tested
- 3D Gait Analysis
- Keywords
- Toe walking, cerebral palsy, idiopathic toe walking, 3D gait analysis
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Gait AnalysisOther
3D gait analysis was applied to children. Static, kinematic and kinetic walking parameters were evaluated
| Study group | Role | What they receive |
|---|---|---|
| ITW Group | 3D gait analysis was applied to children with idiopathic toe walking. Static, kinematic and kinetic walking parameters were evaluated. Receives: Other: 3D Gait Analysis | |
| DCP Group | 3D gait analysis was applied to diparetic children who were able to walk independently. Static, kinematic and kinetic walking parameters were evaluated. Receives: Other: 3D Gait Analysis | |
| Healthy Group | 3D gait analysis was applied to healthy children. Static, kinematic and kinetic walking parameters were evaluated. Receives: Other: 3D Gait Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D Gait Analysis
Sixteen markers defined according to the Modified Helen Heyes protocol are applied to certain anatomical regions of both lower extremities. 3D gait analysis can precisely calculate joint angles and movement patterns in all three planes. Collect spatio-temporal data.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start15 Sep 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih EROL, Biruni University
- Investigators
- Fatih Erol, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142721
- Sponsor's protocol ID
- FEROL
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Walking Parameters Between Idiopathic Toe Walking Children and Children With Independent Walking Diparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06142721
- Acronym / sponsor ID
- FEROL
- Keywords
- Toe walking, cerebral palsy, idiopathic toe walking, 3D gait analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 21 Nov 2023 (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 the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital.
Detailed description
It is an observational study. The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital. 51 cases will be included in our study. These cases will be divided into three groups. The first group will consist of patients diagnosed with idioaptic toe walking (n:17), the second group will be composed of diparetic cerebral palsy (n:15) with independent ambulation, and the third group will be the control group (n:19). First, the demographic information of the cases will be recorded. With 3D walking analysis, kinetic, kinematic and static data will be collected. The analysis of the obtained data will be done with Polygon Software (Vicon, Oxford, UK). Evaluated kinetic, kinematic and static parameters will be compared between three groups.
Is the lower extremity compensation of children with diparetic cerebral palsy who can walk independently more than children with idiopathic toe walking?
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ITW Group | – | Other: 3D Gait Analysis3D gait analysis was applied to children with idiopathic toe walking. Static, kinematic and kinetic walking parameters were evaluated. |
| DCP Group | – | Other: 3D Gait Analysis3D gait analysis was applied to diparetic children who were able to walk independently. Static, kinematic and kinetic walking parameters were evaluated. |
| Healthy Group | – | Other: 3D Gait Analysis3D gait analysis was applied to healthy children. Static, kinematic and kinetic walking parameters were evaluated. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A total of 51 cases, including 17 ITW(female:4;male:13), 15 DCP(female:5;male:10) and 19 Control groups (female:6;male:13), were included.
Key inclusion criteria (4 listed)
- Voluntary consent from family
- Diagnosed with idiopathic toe walking and spastic diparesis between the ages of 3-18.
- Cases with GMFCS 1
- The patients who applied to the healthy children's clinic, showed typical development, did not have any musculoskeletal and neurological problems, and wished to voluntarily participate in the study were included in the control group.
Key exclusion criteria (4 listed)
- Refusing to participate in the study
- Under the age of 3 and over the age of 18
- Not at GMFCS 1 level
- Cases who did not have any orthopedic problems other than accompanying toe walking were excluded from the study.
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 |
|---|---|---|
| 3D Gait Analysis3D gait analysis was applied to children. Static, kinematic and kinetic walking parameters were evaluated | Other | DCP Group, Healthy Group, ITW Group |
Primary outcome
3D Gait Analysis
Time frame: Baseline
Sixteen markers defined according to the Modified Helen Heyes protocol are applied to certain anatomical regions of both lower extremities. 3D gait analysis can precisely calculate joint angles and movement patterns in all three planes. Collect spatio-temporal data.
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 21 Nov 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
Fatih Erol principal investigator
Biruni University
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 Gait Disorders in Children and Cerebral Palsy Spastic Diplegia, run by Biruni 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 4 inclusion and 4 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 21 Nov 2023. 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?
3D Gait Analysis (time frame: Baseline). 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 21 Nov 2023.