NCT04200924

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2.8 years

First QC Date

December 13, 2019

Last Update Submit

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.

Other: Biodex Balance SystemOther: 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.

Other: Biodex Balance SystemOther: Balance Error Scoring System (BESS)

Interventions

For the computerized evaluation of postural control, Biodex Balance System will be used.

Children with idiopathic toe walkingHealthy children

For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.

Children with idiopathic toe walkingHealthy children

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

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)

Location

Study Officials

  • Hulya N Gurses, Prof.

    Bezmialem Vakif University

    STUDY DIRECTOR

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

Locations