Flat FootNCT06606392
Effect of Biodex Balance Training and Short Foot Exercise on Myoelectric Activity of Paraspinal Muscles in Subjects with Flexible Flatfoot
A study testing Biodex balance system and Short Foot Exercise in people with Flat Foot, run by Cairo University at 2 sites in Egypt.
Trial summary
The goal of this study is to see the effect of the combination of biodex balance system and short foot exercise in the treatment of subjects with flexible flat foot. The main question is the effect of biodex balance training and short foot exercise on myoelectric activity of subjects with flexible flat foot… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Flat Foot
- What is being tested?
- Biodex balance system and Short Foot Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 28 Oct 2024to 28 Feb 2025
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) Sixty subjects from both gender with bilateral flexible flat foot will be selected with their age between 18 to 30Years old 2) Body Mass Index (BMI) was ranging from 18 to 25 kg/m2 3) The participants were eligible to be included if had bilaterally FFF according to the navicular drop test 4) Required participant to have been diagnosed (by an orthopedist) with flexible flat foot
Who cannot join
- Repeated lower extremity injuries as fractures or deformities. 2) History of surgery to the lower extremity. 3) History of cerebral concussions, and visual or vestibular disorders. 4) Any neurological deficit affecting balance. 5) Any medication can affect the balance 6) Any problem of lumbar spine( disc,spondylolisthrsis)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Modern university for technology and science
Cairo, Cairo Governorate
Modern university for technology and science
Cairo, Cairo Governorate
Hager Mahmoud Elsayed, Master Degree, 00201118602016, hager.elsherif@hotmail.com
Naguib Salem Professor, Doctoral degree, 0020111806121
About this study
The goal of this study is to see the effect of the combination of biodex balance system and short foot exercise in the treatment of subjects with flexible flat foot. The main question is the effect of biodex balance training and short foot exercise on myoelectric activity of subjects with flexible flat foot experimental participant will receive biodex balance system exercise and short foot exercise for 4 weeks controlled participant will receive short foot exercise and stretching exercise for 4 weeks Assessment will be done pre and post treatment by using Navicular drop test Myoelectric activity of paraspinal muscle Dynamic balance Pain severity Functional ankle instability inder
- Conditions
- Flat Foot
- Being tested
- Biodex balance system, Short Foot Exercise
- Keywords
- Flat foot, Myoelectric activity, Biodex balance
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex balance systemDevice
The Biodex Balance System has a wide range of clinical applications and provides objective measures from testing that can be used to establish progressions and discharge criteria, as well as be part of a comprehensive Fall Risk Assessment or Fall Screening Program. Balance ability can be assessed either statically or dynamically, as well as bilaterally and unilaterally. It also allows for bilateral comparisons between involved and uninvolved limbs.
Short Foot ExerciseOther
Short foot exercise is used as a therapeutic exercise to strengthen intrinsic foot muscles and used as training to create an MLA. It helps improve the balance in functional movement of FF subjects, decreases navicular drop (ND) through intrinsic muscle activation, supports navicular stability, and improves balance
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A 30 subjects will receive short foot exercise and stretching exercise gastrocnemius, soleus muscle and planter fascia stretch. Receives: Other: Short Foot Exercise |
| Group B | Experimental | Group B will receive Biodex balance training and short foot exercise. Receives: Device: Biodex balance system; Other: Short Foot Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle myoelectric activity
myoelectric activity of paraspinal muscles measured by surface electromygraphy
Measured: 4 weeks
Foot print pressure
Using myopressure force platform to measure average peak planter pressure
Measured: 4 weeks
Dynamic balance
Biodex balance system will be used to assess balance before and after treatment
Measured: 4 weeks
Functional ankle instability index
Cumberland Ankle Instability Tool The CAIT is a nine-item questionnaire intended to identify and grade ankle instability
Measured: 4 weeks
Pain severity
Evaluation of lower back pain severity by using visual analogue scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start28 Oct 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flat FootStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- MTI University
- Responsible party
- Principal investigator, Hager Mahmoud mohamed elsayed, MTI University
- Investigators
- Ragia M kamal, Doctoral, Principal investigator, professor of physical therapy , cairo universityNaglaa F Awes, Doctoral, Principal investigator, Assistant professor of physical therapy cairo universiyHend H Mohamed, Doctoral, Principal investigator, Lecturer of physical therapy cairo universityHager M Elsayed, Master, Principal investigator, assistant lecturer of faculty of physical therapy, modern university for technology and science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606392
- Sponsor's protocol ID
- BSM
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.
PubMed 28764143
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biodex Balance Training and Short Foot Exercise on Myoelectric Activity of Paraspinal Muscles in Subjects with Flexible Flatfoot
- ClinicalTrials.gov ID
- NCT06606392
- Acronym / sponsor ID
- BSM
- Conditions
- Flat Foot
- Keywords
- Flat foot, Myoelectric activity, Biodex balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- MTI University
- Study start
- 28 Oct 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 23 Sep 2024 (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 goal of this study is to see the effect of the combination of biodex balance system and short foot exercise in the treatment of subjects with flexible flat foot. The main question is the effect of biodex balance training and short foot exercise on myoelectric activity of subjects with flexible flat foot experimental participant will receive biodex balance system exercise and short foot exercise for 4 weeks controlled participant will receive short foot exercise and stretching exercise for 4 weeks Assessment will be done pre and post treatment by using Navicular drop test Myoelectric activity of paraspinal muscle Dynamic balance Pain severity Functional ankle instability inder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Short Foot ExerciseGroup A 30 subjects will receive short foot exercise and stretching exercise gastrocnemius, soleus muscle and planter fascia stretch. |
| Group B | Experimental | Device: Biodex balance system, Other: Short Foot ExerciseGroup B will receive Biodex balance training and short foot exercise. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Sixty subjects from both gender with bilateral flexible flat foot will be selected with their age between 18 to 30Years old 2) Body Mass Index (BMI) was ranging from 18 to 25 kg/m2 3) The participants were eligible to be included if had bilaterally FFF according to the navicular drop test 4) Required participant to have been diagnosed (by an orthopedist) with flexible flat foot
Key exclusion criteria (1 listed)
- Repeated lower extremity injuries as fractures or deformities. 2) History of surgery to the lower extremity. 3) History of cerebral concussions, and visual or vestibular disorders. 4) Any neurological deficit affecting balance. 5) Any medication can affect the balance 6) Any problem of lumbar spine( disc,spondylolisthrsis)
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 |
|---|---|---|
| Biodex balance systemThe Biodex Balance System has a wide range of clinical applications and provides objective measures from testing that can be used to establish progressions and discharge criteria, as well as be part of a comprehensive Fall Risk Assessment or Fall Screening Program. Balance ability can be assessed either statically or dynamically, as well as bilaterally and unilaterally. It also allows for bilateral comparisons between involved and uninvolved limbs. | Device | Group B |
| Short Foot ExerciseShort foot exercise is used as a therapeutic exercise to strengthen intrinsic foot muscles and used as training to create an MLA. It helps improve the balance in functional movement of FF subjects, decreases navicular drop (ND) through intrinsic muscle activation, supports navicular stability, and improves balance | Other | Group A, Group B |
Primary outcome
Muscle myoelectric activity
Time frame: 4 weeks
myoelectric activity of paraspinal muscles measured by surface electromygraphy
Foot print pressure
Time frame: 4 weeks
Using myopressure force platform to measure average peak planter pressure
Dynamic balance
Time frame: 4 weeks
Biodex balance system will be used to assess balance before and after treatment
Functional ankle instability index
Time frame: 4 weeks
Cumberland Ankle Instability Tool The CAIT is a nine-item questionnaire intended to identify and grade ankle instability
Pain severity
Time frame: 4 weeks
Evaluation of lower back pain severity by using visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 28764143Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.
- Individual participant dataSharing planned: Yes
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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.
Ragia M kamal, Doctoral principal investigator
professor of physical therapy , cairo university
Naglaa F Awes, Doctoral principal investigator
Assistant professor of physical therapy cairo universiy
Hend H Mohamed, Doctoral principal investigator
Lecturer of physical therapy cairo university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex balance system and Short Foot Exercise in people with Flat Foot, run by Cairo University at 2 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hager M Elsayed, Master degree (+201118602016, Hager.elsherif@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle myoelectric activity (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606392, which also lists 1 linked publication.
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 Sep 2024.