Flat FeetNCT05026294
Plyometric Exercise With Obese Children
A study testing plyometric exercises and Exercises for flat feet rehabilitation in people with Flat Feet, run by Taif University at 1 site in Saudi Arabia.
Trial summary
Obesity is one of the main factors that contribute to an acquired flat foot deformity which in turn impairs the balance strategies. The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture, and functional mobility in obese children… Read more about this study
- Who is it for?
- Ages 7 to 11 years, men only
- Conditions the study is for
- Flat Feet
- What is being tested?
- plyometric exercises and Exercises for flat feet rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2020to 13 May 2021
- 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 7 to 11 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Body mass index percentile equal to or greater than the 95th percentile
- All had no previous history of strength or balance training or involvement in competitive sports emphasizing muscular strength or balance.
- All participants had balance deficiency and mobile flat foot.
Who cannot join
- Previous injury to the lower limb required medical care.
- Confounding conditions, such as a deformity of or surgery in the lower limb.
- visual impairment, or neuromuscular disorders.
- engagement in obesity treatment programs, three months prior to the study.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Applied Medical Sciences
Ta'if, Mecca Region, 62552
About this study
Official title: Effects of Plyometric Exercises Versus Flatfoot Corrective Exercises on Postural Control and Foot Posture in Obese Children With Flexible Flatfoot
Obesity is one of the main factors that contribute to an acquired flat foot deformity which in turn impairs the balance strategies. The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture, and functional mobility in obese children with flexible flatfoot.
Read the detailed description
A sample of 47 male children participated in the current study. The participants were selected from different elementary schools in Taif, Saudi Arabia. Their age ranged from 7 to 11 years. the sample was randomly divided into 3 groups: the experimental group I, (EGI), the experimental group II, (EGII), and the control group (CG). The EGI received a plyometric exercise program. The EGII received the corrective exercises 2 sessions per week for 10 weeks. The control group did not perform any planned physical activities during the intervention period but continued in their routine physical activities. The Prokin system was used to assess the static balance, timed up and go test was used to assess functional mobility, and Navicular drop test was used to assess the degree of flatfoot deformity, prior to and after the intervention for all groups.
- Conditions
- Flat Feet
- Being tested
- plyometric exercises, Exercises for flat feet rehabilitation
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plyometric exercisesOther
Exercises for strength and flexibility
Exercises for flat feet rehabilitationOther
Exercises for intrinsic muscles strength
| Study group | Role | What they receive |
|---|---|---|
| Experimental group I | Experimental | The experimental group received plyometric training Receives: Other: plyometric exercises |
| Experimental group II | Experimental | The experimental group received flat feet rehabilitation training Receives: Other: Exercises for flat feet rehabilitation |
| Control group | No intervention | The Control group didn't receive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot posture
condition of the medial longitudinal arch of the foot
Measured: 10 weeks
Balance (measure 1)
Perimeter area (mm).
Measured: 10 weeks
Balance (measure 2)
Ellipse area (mm2).
Measured: 10 weeks
Balance (measure 3)
Standard backward-forward deviation.
Measured: 10 weeks
Balance (measure 4)
Standard medial-lateral deviation.
Measured: 10 weeks
Functional mobility
Timed up and go test
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Dec 2020
- Primary completion1 Apr 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat FeetStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Pretest-posttest control group design was used. A sample of 47 male children participated in the current study. After gathering the baseline measurements, the participants were randomly assigned into three groups: experimental group I, (EGI) contained 16 participants, experimental group II (EGII) contained 16 participants, and control group, (CG) contained 15. The stratification was done using sealed envelopes. The children were not aware of their group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Allam, Taif University
- Investigators
- Hatem Allam, A.professor, Principal investigator, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026294
- Sponsor's protocol ID
- HAP-02-T-067- 452
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plyometric Exercises Versus Flatfoot Corrective Exercises on Postural Control and Foot Posture in Obese Children With Flexible Flatfoot
- ClinicalTrials.gov ID
- NCT05026294
- Acronym / sponsor ID
- HAP-02-T-067- 452
- Conditions
- Flat Feet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 30 Aug 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 one of the main factors that contribute to an acquired flat foot deformity which in turn impairs the balance strategies. The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture, and functional mobility in obese children with flexible flatfoot.
Detailed description
A sample of 47 male children participated in the current study. The participants were selected from different elementary schools in Taif, Saudi Arabia. Their age ranged from 7 to 11 years. the sample was randomly divided into 3 groups: the experimental group I, (EGI), the experimental group II, (EGII), and the control group (CG). The EGI received a plyometric exercise program. The EGII received the corrective exercises 2 sessions per week for 10 weeks. The control group did not perform any planned physical activities during the intervention period but continued in their routine physical activities. The Prokin system was used to assess the static balance, timed up and go test was used to assess functional mobility, and Navicular drop test was used to assess the degree of flatfoot deformity, prior to and after the intervention for all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A Pretest-posttest control group design was used. A sample of 47 male children participated in the current study. After gathering the baseline measurements, the participants were randomly assigned into three groups: experimental group I, (EGI) contained 16 participants, experimental group II (EGII) contained 16 participants, and control group, (CG) contained 15. The stratification was done using sealed envelopes. The children were not aware of their group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group I | Experimental | Other: plyometric exercisesThe experimental group received plyometric training |
| Experimental group II | Experimental | Other: Exercises for flat feet rehabilitationThe experimental group received flat feet rehabilitation training |
| Control group | No intervention | –The Control group didn't receive intervention |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Body mass index percentile equal to or greater than the 95th percentile
- All had no previous history of strength or balance training or involvement in competitive sports emphasizing muscular strength or balance.
- All participants had balance deficiency and mobile flat foot.
Key exclusion criteria (4 listed)
- Previous injury to the lower limb required medical care.
- Confounding conditions, such as a deformity of or surgery in the lower limb.
- visual impairment, or neuromuscular disorders.
- engagement in obesity treatment programs, three months prior to the study.
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 |
|---|---|---|
| plyometric exercisesExercises for strength and flexibility | Other | Experimental group I |
| Exercises for flat feet rehabilitationExercises for intrinsic muscles strength | Other | Experimental group II |
Primary outcome
Foot posture
Time frame: 10 weeks
condition of the medial longitudinal arch of the foot
Balance (measure 1)
Time frame: 10 weeks
Perimeter area (mm).
Balance (measure 2)
Time frame: 10 weeks
Ellipse area (mm2).
Balance (measure 3)
Time frame: 10 weeks
Standard backward-forward deviation.
Balance (measure 4)
Time frame: 10 weeks
Standard medial-lateral deviation.
Functional mobility
Time frame: 10 weeks
Timed up and go test
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 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Flat Feet
Not yet recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
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.
Hatem Allam, A.professor principal investigator
Taif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plyometric exercises and Exercises for flat feet rehabilitation in people with Flat Feet, run by Taif University at 1 site in Saudi Arabia.
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 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 30 Aug 2021. 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 Saudi Arabia. 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?
Foot posture (time frame: 10 weeks). The study lists 6 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 30 Aug 2021.