Use of Walkers in Infancy and Musculoskeletal System

June 2, 2023 updated by: Ozden Gokcek

The Effect of the Use of a Walker in Infancy on the Musculoskeletal System and the Level of Physical Activity

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aimed to compare lower extremity muscle strength, postural disorders, and physical activity levels of children who used and did not use a walker during infancy.

The study included 39 children aged between 8 and 15 years. The demographic information of the children, their motor development stages and walker use situations, the age at which they started using it, and the duration of use were questioned. The New York Posture Analysis Questionnaire and Physical Activity Assessment Questionnaire Scale (PAQ-C) were administered to the children. Muscle strength was measured with a digital muscle strength meter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Karsıyaka
      • Izmir, Karsıyaka, Turkey, 35575
        • Ege University Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Using Walker Group
Children who used baby walkers during childhood were included in this group. All assessment procedures were then performed.
Diagnostic test: Posture Analysis
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.
Other Names:
  • New York Posture Analysis
Diagnostic test: Physical activity level
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.
Other Names:
  • Physical Activity Questionnaire for Children (PAQ-C)
Diagnostic test: Muscle strength

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.

Other Names:
  • Digital Muscle Strength Meter
Active Comparator: Walker-Free Group
Children who did not use a baby walker during childhood were included in this group. All assessment procedures were then performed.
Diagnostic test: Posture Analysis
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.
Other Names:
  • New York Posture Analysis
Diagnostic test: Physical activity level
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.
Other Names:
  • Physical Activity Questionnaire for Children (PAQ-C)
Diagnostic test: Muscle strength

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.

Other Names:
  • Digital Muscle Strength Meter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 6 months
JTech Commander PowerTrack Muscle Dynamometer
6 months
Physical activity level
Time Frame: 6 months
Physical Activity Questionnaire for Children (PAQ-C)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Posture analysis
Time Frame: 6 months
New York Posture Analysis Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ozden Gokcek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

It can be requested within a period of two years from the year of publication of the work.

IPD Sharing Access Criteria

If the data are necessary for the conduct or conclusion of another study, they may be requested from the author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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