Ankle InjuriesNCT05074511
Weight Variations Impacts on the Ankle of the Child
An observational study of Ankle Injuries and Risk of Falling, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Obesity is a global health problem. It changes the measurement of the human body and makes a big change to move the body. The increased weight and mass change the way the limbs and whole body generate and react to force Excess fat also interferes with joint-muscle interactions that are important for functional… Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Ankle Injuries, Risk of Falling, Stability
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 31 Oct 2022
- Phase
- Observational
- 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 7 to 9 years
- All sexes
- Child
Study population: Two hundred healthy non-athletic children from both sexes will participate in this study. They will randomly be recruited from primary school stage.
Who may be able to join
- Their age will be ranging from 7 to 9 years.
- All children have normal stature for age percentile according to CDC chart.
- The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts
- All children are normal \&perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Who cannot join
- All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention in the lower extremities.
- None of them had any history of musculoskeletal deformities or neuromuscular disorders.
- They had neither visual, auditory defect.
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is a global health problem. It changes the measurement of the human body and makes a big change to move the body. The increased weight and mass change the way the limbs and whole body generate and react to force Excess fat also interferes with joint-muscle interactions that are important for functional capacity and postural balance The tendency to increase the thickness of the abdomen contributes to anterior movement of the COM of the body. The purpose of the study is to investigate the biomechanical effect of weight on foot stability in children.
- Conditions
- Ankle Injuries, Risk of Falling, Stability
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy | Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles | |
| overweight | Children in this group will be overweight category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 85th to 95th percentiles . | |
| obese | Children in this group will be obese category according to CDC chart which ranged from BMI-for-age > 95th percentiles | |
| underweight | Children in this group will be underweight category according to CDC chart ranged from BMI-for-age < 5th percentiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of falling in static and dynamic situations for each group
The Biodex Balance System will be used to assess risk of falling
Measured: assessed immediately after the procedure
dynamic level of stability for each group
The Biodex Balance System will be used to assess level of instability
Measured: assessed immediately after the procedure
dynamic Postural stability for each group
The Biodex Balance System will be used to assess Postural stability
Measured: aassessed immediately after the procedure
ankle muscles peak and angle specific torque, power and work for each group
Isokinetic dynamometer will be used to assess ankle muscles (plantarflexors, dorsiflexors, inverstors and evertors muscles). it will be assess the peak and angle specific torque, power and work for those muscles.
Measured: assessed immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start15 Oct 2021
- Primary completion28 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074511
- Sponsor's protocol ID
- ankle stability
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Variations Impacts on the Ankle of the Child
- ClinicalTrials.gov ID
- NCT05074511
- Acronym / sponsor ID
- ankle stability
- Conditions
- Ankle Injuries, Risk of Falling, Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Oct 2021 (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.
Obesity is a global health problem. It changes the measurement of the human body and makes a big change to move the body. The increased weight and mass change the way the limbs and whole body generate and react to force Excess fat also interferes with joint-muscle interactions that are important for functional capacity and postural balance The tendency to increase the thickness of the abdomen contributes to anterior movement of the COM of the body. The purpose of the study is to investigate the biomechanical effect of weight on foot stability in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy | – | –Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles |
| overweight | – | –Children in this group will be overweight category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 85th to 95th percentiles . |
| obese | – | –Children in this group will be obese category according to CDC chart which ranged from BMI-for-age > 95th percentiles |
| underweight | – | –Children in this group will be underweight category according to CDC chart ranged from BMI-for-age < 5th percentiles |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Age groups
- Child
- Study population
- Two hundred healthy non-athletic children from both sexes will participate in this study. They will randomly be recruited from primary school stage.
Key inclusion criteria (5 listed)
- Their age will be ranging from 7 to 9 years.
- All children have normal stature for age percentile according to CDC chart.
- The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts
- All children are normal \&perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Key exclusion criteria (4 listed)
- All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention in the lower extremities.
- None of them had any history of musculoskeletal deformities or neuromuscular disorders.
- They had neither visual, auditory defect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
risk of falling in static and dynamic situations for each group
Time frame: assessed immediately after the procedure
The Biodex Balance System will be used to assess risk of falling
dynamic level of stability for each group
Time frame: assessed immediately after the procedure
The Biodex Balance System will be used to assess level of instability
dynamic Postural stability for each group
Time frame: aassessed immediately after the procedure
The Biodex Balance System will be used to assess Postural stability
ankle muscles peak and angle specific torque, power and work for each group
Time frame: assessed immediately after the procedure
Isokinetic dynamometer will be used to assess ankle muscles (plantarflexors, dorsiflexors, inverstors and evertors muscles). it will be assess the peak and angle specific torque, power and work for those muscles.
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 23 Jan 2024.
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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?
An observational study of Ankle Injuries and Risk of Falling, run by Delta University for Science and Technology at 1 site in Egypt.
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 5 inclusion and 4 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 23 Jan 2024. 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 Egypt. 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?
risk of falling in static and dynamic situations for each group (time frame: assessed immediately after the procedure). The study lists 4 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 23 Jan 2024.