Evaluation of Postural Control in Children With Idiopathic Toe Walking
1 other identifier
observational
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 13, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJuly 20, 2022
July 1, 2022
2.8 years
December 13, 2019
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Postural control-postural stability
Computerized test of postural stability with Biodex Balance System
1 day
Postural control-limits of stability
Computerized test of limits of stability with Biodex Balance System
1 day
Postural control-sensory integration
Computerized test of sensory integration with Biodex Balance System
1 day
Balance Error Scorring System-BESS
Clinical evaluation of postural control
1 day
Study Arms (2)
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.
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.
Interventions
For the computerized evaluation of postural control, Biodex Balance System will be used.
For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- A history of BoNT-A or surgery in the last 6 months
- Presence of leg length discrepancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
Study Officials
- STUDY DIRECTOR
Hulya N Gurses, Prof.
Bezmialem Vakif University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer in Department of Physiotheray and Rehabilitation, Bezmialem Vakif University
Study Record Dates
First Submitted
December 13, 2019
First Posted
December 16, 2019
Study Start
June 1, 2019
Primary Completion
March 1, 2022
Study Completion
May 1, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07