ClinicalTrials.gg
Not yet recruitingNCT06606392Updated Sep 23, 2024

Effect of Biodex Balance Training and Short Foot Exercise on Myoelectric Activity of Paraspinal Muscles in Subjects with Flexible Flatfoot

An interventional study of Biodex balance system and Short Foot Exercise in Flat Foot, sponsored by Cairo University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Flat Foot

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Keywords

  • Flat foot, Myoelectric activity, Biodex balance
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Sixty subjects from both gender with bilateral flexible flat foot will be selected with their age between 18 to 30Years old 2) (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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Group A

    Group A 30 subjects will receive short foot exercise and stretching exercise gastrocnemius, soleus muscle and planter fascia stretch.

    Other: Short Foot Exercise

  • Experimental
    Group B

    Group B will receive Biodex balance training and short foot exercise.

    Device: Biodex balance system · Other: Short Foot Exercise

Interventions

  • DeviceBiodex balance system

    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.

  • OtherShort Foot Exercise

    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

06

What researchers measure

Primary outcomes

  1. Muscle myoelectric activity

    myoelectric activity of paraspinal muscles measured by surface electromygraphy

    Time frame: 4 weeks

  2. Foot print pressure

    Using myopressure force platform to measure average peak planter pressure

    Time frame: 4 weeks

  3. Dynamic balance

    Biodex balance system will be used to assess balance before and after treatment

    Time frame: 4 weeks

  4. Functional ankle instability index

    Cumberland Ankle Instability Tool The CAIT is a nine-item questionnaire intended to identify and grade ankle instability

    Time frame: 4 weeks

  5. Pain severity

    Evaluation of lower back pain severity by using visual analogue scale

    Time frame: 4 weeks

07

Study locations

2 sites
  • Modern university for technology and science
    Cairo, Egypt
  • Modern university for technology and science
    Cairo, Egypt
    • Hager Mahmoud Elsayed, Master Degree · Contacthager.elsherif@hotmail.com · 00201118602016
    • Naguib Salem Professor, Doctoral degree · Contact0020111806121
    • Hager Mahmoud Elsayed, Master degree · Contact
    • Ragia Mohamed kamal, Doctoral · Contact
    • Naglaa Fathy Awes, Doctoral · Contact
    • Hend Hamdy Mohamed, Doctoral · Contact
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Feb 2025, 4 months later.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 4 months is below that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2024
First posted
Sep 23, 2024
StartEst.
Oct 28, 2024
Primary completionEst.
Feb 28, 2025
CompletionEst.
Feb 28, 2025
Last update
Sep 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06606392
Lead sponsor
Cairo University
Collaborators
MTI University
Responsible party
Hager Mahmoud mohamed elsayed (Assistant lecturer basic science department of faculty of physical therapy modern university for technology and science, MTI University) — Principal investigator
First posted
Sep 23, 2024
Start date
Oct 28, 2024 (estimated)
Primary completion
Feb 28, 2025 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Sep 23, 2024

Study contacts

Hager M Elsayed, Master degree
Contact
Hager.elsherif@hotmail.com
+201118602016
Hend H Mohamed, Doctoral degree
Contact
Hendhamdy110@yahoo.com
+201226827307
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
Hager M Elsayed, Master
principal investigator · assistant lecturer of faculty of physical therapy, modern university for technology and science

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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