NCT05899803

Brief Summary

The aim of this study was to compare lower extremity muscle strength, posture disorders and physical activity levels of children with and without walker use during infancy. Thirty-nine children aged between 8 and 15 years were included. Demographic data, New York Posture Analysis Questionnaire and Physical Activity Assessment Questionnaire Scale (PAQ-C) were collected. Muscle strength was measured with a digital muscle strength meter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 23, 2023

Last Update Submit

June 2, 2023

Conditions

Keywords

Baby equipmentphysical activitymuscle strengthposturewalker

Outcome Measures

Primary Outcomes (2)

  • Muscle strength

    JTech Commander PowerTrack Muscle Dynamometer

    6 months

  • Physical activity level

    Physical Activity Questionnaire for Children (PAQ-C)

    6 months

Secondary Outcomes (1)

  • Posture analysis

    6 months

Study Arms (2)

Using Walker Group

EXPERIMENTAL

Children who used baby walkers during childhood were included in this group. All assessment procedures were then performed.

Diagnostic Test: Posture AnalysisDiagnostic Test: Physical activity levelDiagnostic Test: Muscle strength

Walker-Free Group

ACTIVE COMPARATOR

Children who did not use a baby walker during childhood were included in this group. All assessment procedures were then performed.

Diagnostic Test: Posture AnalysisDiagnostic Test: Physical activity levelDiagnostic Test: Muscle strength

Interventions

Posture AnalysisDIAGNOSTIC_TEST

This analysis consists of 13 different body parts and evaluates the body in terms of current posture changes. Our study evaluated children from two angles: posterior (head, shoulders, back, hips, feet, and arches) and lateral (neck, chest, shoulders, upper back, trunk, abdomen, and waist). In the scoring system, correct posture was recorded as five points, a moderate amount of deformity posture as three points, and severe deformity posture as one point. The total score calculated at the end of the questionnaire was a maximum of 65 points and a minimum of 13 points. The results of the analysis were evaluated as follows: ≥ 45 points, very good, 40-44 points good, 30-39 points moderate, 20-29 points poor, and a total score of ≤ 19 points.

Also known as: New York Posture Analysis
Using Walker GroupWalker-Free Group

This questionnaire, administered to children aged 4-14, evaluates the activities performed during a week. The questionnaire consisted of nine questions, each of which was evaluated on a 5 points. One point indicated a low physical activity level and five points indicated a high physical activity level. Dividing the total score of the selected items by the number of items gives a summary score for the PAQ-C questionnaire. In our study, we used the Turkish version of the questionnaire, which was found to be reliable and valid.

Also known as: Physical Activity Questionnaire for Children (PAQ-C)
Using Walker GroupWalker-Free Group
Muscle strengthDIAGNOSTIC_TEST

Our study objectively measured muscle strength using the JTech Commander PowerTrack Muscle Dynamometer. Right and left muscle tests: Hip flexors/hyperextensors/adductors/abductors/internal rotators/external retractors, knee flexors/extensors, and foot plantar flexors/dorsiflexors were evaluated. The measurement results were recorded in Newtons, the measurements were repeated three times, and the average of these three repetitions was recorded.

Also known as: Digital Muscle Strength Meter
Using Walker GroupWalker-Free Group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • No idiopathic serious orthopedic problems
  • No chronic disease
  • Children and their parents who volunteered to participate in the study

You may not qualify if:

  • Presence of neurologic disease.
  • Presence of neuromuscular disease.
  • Presence of mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege university faculty of health sciences

Izmir, Karsıyaka, 35575, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Muscle Strength

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 12, 2023

Study Start

January 3, 2022

Primary Completion

April 30, 2022

Study Completion

June 5, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

When deemed appropriate, data can be requested from the corresponding author via e-mail.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
It can be requested within a period of two years from the year of publication of the work.
Access Criteria
If the data are necessary for the conduct or conclusion of another study, they may be requested from the author.

Locations