- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05899803
Use of Walkers in Infancy and Musculoskeletal System
The Effect of the Use of a Walker in Infancy on the Musculoskeletal System and the Level of Physical Activity
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karsıyaka
-
Izmir, Karsıyaka, Turkey, 35575
- Ege university faculty of health sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
---|---|
Experimental: Using Walker Group
Children who used baby walkers during childhood were included in this group.
All assessment procedures were then performed.
|
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:
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:
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:
|
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.
|
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:
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:
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:
|
What is the study measuring?
Primary Outcome Measures
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posture analysis
Time Frame: 6 months
|
New York Posture Analysis Questionnaire
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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