Use of a Walker in InfancyNCT05899803
Use of Walkers in Infancy and Musculoskeletal System
A study testing Posture Analysis, Physical activity level and Muscle strength in people with Use of a Walker in Infancy and Physical Activity Level, run by Ozden Gokcek at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Use of a Walker in Infancy, Physical Activity Level, Musculoskeletal Problems
- What is being tested?
- Posture Analysis, Physical activity level and Muscle strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2022to 5 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No idiopathic serious orthopedic problems
- No chronic disease
- Children and their parents who volunteered to participate in the study
Who cannot join
- Presence of neurologic disease.
- Presence of neuromuscular disease.
- Presence of mental retardation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege university faculty of health sciences
Izmir, Karsıyaka, 35575
About this study
Official title: 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.
Read the 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.
- Being tested
- Posture Analysis, Physical activity level, Muscle strength
- Keywords
- Baby equipment, physical activity, muscle strength, posture, walker
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture AnalysisDiagnostic test
Also called New York 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.
Physical activity levelDiagnostic test
Also called Physical Activity Questionnaire for Children (PAQ-C)
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.
Muscle strengthDiagnostic test
Also called Digital Muscle Strength Meter
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.
| Study group | Role | What they receive |
|---|---|---|
| Using Walker Group | Experimental | Children who used baby walkers during childhood were included in this group. All assessment procedures were then performed. Receives: Diagnostic Test: Posture Analysis; Diagnostic Test: Physical activity level; Diagnostic 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. Receives: Diagnostic Test: Posture Analysis; Diagnostic Test: Physical activity level; Diagnostic Test: Muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
JTech Commander PowerTrack Muscle Dynamometer
Measured: 6 months
Physical activity level
Physical Activity Questionnaire for Children (PAQ-C)
Measured: 6 months
Secondary outcomes (1)
Posture analysis
New York Posture Analysis Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start3 Jan 2022
- Primary completion30 Apr 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of a Walker in InfancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozden Gokcek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ozden Gokcek, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899803
- Sponsor's protocol ID
- 2023/23
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When deemed appropriate, data can be requested from the corresponding author via e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of a Walker in Infancy on the Musculoskeletal System and the Level of Physical Activity
- ClinicalTrials.gov ID
- NCT05899803
- Acronym / sponsor ID
- 2023/23
- Keywords
- Baby equipment, physical activity, muscle strength, posture, walker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ozden GokcekUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using Walker Group | Experimental | Diagnostic Test: Posture Analysis, Diagnostic Test: Physical activity level, Diagnostic Test: Muscle strengthChildren who used baby walkers during childhood were included in this group. All assessment procedures were then performed. |
| Walker-Free Group | Active comparator | Diagnostic Test: Posture Analysis, Diagnostic Test: Physical activity level, Diagnostic Test: Muscle strengthChildren who did not use a baby walker during childhood were included in this group. All assessment procedures were then performed. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No idiopathic serious orthopedic problems
- No chronic disease
- Children and their parents who volunteered to participate in the study
Key exclusion criteria (3 listed)
- Presence of neurologic disease.
- Presence of neuromuscular disease.
- Presence of mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posture AnalysisAlso: New York Posture AnalysisThis 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. | Diagnostic test | Using Walker Group, Walker-Free Group |
| Physical activity levelAlso: Physical Activity Questionnaire for Children (PAQ-C)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. | Diagnostic test | Using Walker Group, Walker-Free Group |
| Muscle strengthAlso: Digital Muscle Strength MeterOur 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. | Diagnostic test | Using Walker Group, Walker-Free Group |
Primary outcome
Muscle strength
Time frame: 6 months
JTech Commander PowerTrack Muscle Dynamometer
Physical activity level
Time frame: 6 months
Physical Activity Questionnaire for Children (PAQ-C)
1 secondary outcome
Posture analysis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: Yes. When deemed appropriate, data can be requested from the corresponding author via e-mail.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posture Analysis, Physical activity level and Muscle strength in people with Use of a Walker in Infancy and Physical Activity Level, run by Ozden Gokcek at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.