NCT06606392

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 18, 2024

Last Update Submit

September 18, 2024

Conditions

Keywords

Flat foot, Myoelectric activity, Biodex balance

Outcome Measures

Primary Outcomes (5)

  • Muscle myoelectric activity

    myoelectric activity of paraspinal muscles measured by surface electromygraphy

    4 weeks

  • Foot print pressure

    Using myopressure force platform to measure average peak planter pressure

    4 weeks

  • Dynamic balance

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

    4 weeks

  • Functional ankle instability index

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

    4 weeks

  • Pain severity

    Evaluation of lower back pain severity by using visual analogue scale

    4 weeks

Study Arms (2)

Group A

OTHER

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

Other: Short Foot Exercise

Group B

EXPERIMENTAL

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

Device: Biodex balance systemOther: Short Foot Exercise

Interventions

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.

Group B

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

Group AGroup B

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Modern university for technology and science

Cairo, Cairo Governorate, Egypt

Location

Modern university for technology and science

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 28764143BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ragia M kamal, Doctoral

    professor of physical therapy , cairo university

    PRINCIPAL INVESTIGATOR
  • Naglaa F Awes, Doctoral

    Assistant professor of physical therapy cairo universiy

    PRINCIPAL INVESTIGATOR
  • Hend H Mohamed, Doctoral

    Lecturer of physical therapy cairo university

    PRINCIPAL INVESTIGATOR
  • Hager M Elsayed, Master

    assistant lecturer of faculty of physical therapy, modern university for technology and science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hager M Elsayed, Master degree

CONTACT

Hend H Mohamed, Doctoral degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer basic science department of faculty of physical therapy modern university for technology and science

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 23, 2024

Study Start

October 28, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations