Idiopathic Toe WalkingNCT04200924
Evaluation of Postural Control in Children With Idiopathic Toe Walking
An observational study of Idiopathic Toe Walking and Gait Disorders in Children, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System), which is reported to be a reliable and valid instrument for detecting changes in balance and postural control in the literature. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Toe Walking, Gait Disorders in Children, Postural Control
- What is being tested?
- Biodex Balance System and Balance Error Scoring System (BESS)
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 May 2022
- How long will I take part?
- 1 Day
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 16 children with idiopathic toe walking aged 6-15 years followed by Bezmialem Vakıf University Department of Orthopedics and Traumatology. 16 healthy volunteers aged 6-15 years will be included in the control group.
Who may be able to join
- Having the diagnosis of idiopathic toe walking
- No contact with the heel in the initial contact phase of the gait
- Presence of bilateral toe walking gait
- Normal neurological and orthopedic examination results
- Achievement of independent walking before 18 months
- Absence of pervasive developmental disorder or autism
Who cannot join
- A history of BoNT-A or surgery in the last 6 months
- Presence of leg length discrepancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System), which is reported to be a reliable and valid instrument for detecting changes in balance and postural control in the literature.
Read the detailed description
Idiopathic toe walking (ITW) is a term used to describe the condition in which children walk with a toe-toe gait pattern in the absence of any known cause. When the literature is examined, it is reported that a possible neuromechanism of idiopathic toe walking is related to postural disorder and a deterioration of sensory information coming from the proprioceptive, vestibular, visual and / or tactile systems. The most important function of the posture is to maintain the balance during the initiation and continuation of the movement. Postural control regulates maintaining the balance and keeping the center of gravity within the body's stability limits. It includes resistance to gravity forces and mechanical support during movement. Postural control is an integral part of achieving targeted action. Although there are few studies showing the possible relationship, no studies have been found to evaluate postural control by computerized posturography in these children. In this study, we aimed to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System).
- Conditions
- Idiopathic Toe Walking, Gait Disorders in Children, Postural Control, Postural Stability, Balance
- Being tested
- Biodex Balance System, Balance Error Scoring System (BESS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balance SystemOther
For the computerized evaluation of postural control, Biodex Balance System will be used.
Balance Error Scoring System (BESS)Other
For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Children with idiopathic toe walking | After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. Receives: Other: Biodex Balance System; Other: Balance Error Scoring System (BESS) | |
| Healthy children | After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. Receives: Other: Biodex Balance System; Other: Balance Error Scoring System (BESS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control-postural stability
Computerized test of postural stability with Biodex Balance System
Measured: 1 day
Postural control-limits of stability
Computerized test of limits of stability with Biodex Balance System
Measured: 1 day
Postural control-sensory integration
Computerized test of sensory integration with Biodex Balance System
Measured: 1 day
Balance Error Scorring System-BESS
Clinical evaluation of postural control
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Jun 2019
- Primary completion1 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Toe WalkingStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
- Investigators
- Hulya N Gurses, Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200924
- Sponsor's protocol ID
- DT-02
- Status last verified
- Jul 2022
- First submitted
- 13 Dec 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postural Control in Children With Idiopathic Toe Walking
- ClinicalTrials.gov ID
- NCT04200924
- Acronym / sponsor ID
- DT-02
- Conditions
- Idiopathic Toe Walking, Gait Disorders in Children, Postural Control, Postural Stability, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 16 Dec 2019 (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 is to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System), which is reported to be a reliable and valid instrument for detecting changes in balance and postural control in the literature.
Detailed description
Idiopathic toe walking (ITW) is a term used to describe the condition in which children walk with a toe-toe gait pattern in the absence of any known cause. When the literature is examined, it is reported that a possible neuromechanism of idiopathic toe walking is related to postural disorder and a deterioration of sensory information coming from the proprioceptive, vestibular, visual and / or tactile systems. The most important function of the posture is to maintain the balance during the initiation and continuation of the movement. Postural control regulates maintaining the balance and keeping the center of gravity within the body's stability limits. It includes resistance to gravity forces and mechanical support during movement. Postural control is an integral part of achieving targeted action. Although there are few studies showing the possible relationship, no studies have been found to evaluate postural control by computerized posturography in these children. In this study, we aimed to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with idiopathic toe walking | – | Other: Biodex Balance System, Other: Balance Error Scoring System (BESS)After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. |
| Healthy children | – | Other: Biodex Balance System, Other: Balance Error Scoring System (BESS)After the demographic information, developmental history and gait information were recorded with the Evaluation Form, clinical evaluation was performed; bilateral lower extremity range of motion, flexibility, leg length measurement, and muscle strength measurement and muscular endurance tests (abdominal, back and lower extremity) will be performed. For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) and the Biodex Balance System for computerized evaluation will be used. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 16 children with idiopathic toe walking aged 6-15 years followed by Bezmialem Vakıf University Department of Orthopedics and Traumatology. 16 healthy volunteers aged 6-15 years will be included in the control group.
Key inclusion criteria (6 listed)
- Having the diagnosis of idiopathic toe walking
- No contact with the heel in the initial contact phase of the gait
- Presence of bilateral toe walking gait
- Normal neurological and orthopedic examination results
- Achievement of independent walking before 18 months
Key exclusion criteria (2 listed)
- A history of BoNT-A or surgery in the last 6 months
- Presence of leg length discrepancy
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 |
|---|---|---|
| Biodex Balance SystemFor the computerized evaluation of postural control, Biodex Balance System will be used. | Other | Children with idiopathic toe walking, Healthy children |
| Balance Error Scoring System (BESS)For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used. | Other | Children with idiopathic toe walking, Healthy children |
Primary outcome
Postural control-postural stability
Time frame: 1 day
Computerized test of postural stability with Biodex Balance System
Postural control-limits of stability
Time frame: 1 day
Computerized test of limits of stability with Biodex Balance System
Postural control-sensory integration
Time frame: 1 day
Computerized test of sensory integration with Biodex Balance System
Balance Error Scorring System-BESS
Time frame: 1 day
Clinical evaluation of postural control
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 20 Jul 2022.
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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.
Hulya N Gurses, Prof. study director
Bezmialem Vakif 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 Idiopathic Toe Walking and Gait Disorders in Children, run by Bezmialem Vakif 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 6 inclusion and 2 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 20 Jul 2022. 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?
Postural control-postural stability (time frame: 1 day). The study lists 4 primary outcomes in all. 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 20 Jul 2022.