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

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 Overview

• Status: Not yet recruiting
• Conditions: Flat Foot
• Intervention / Treatment: Other: Short Foot Exercise; Device: Biodex balance system

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hager M Elsayed, Master degree; Phone Number: +201118602016; Email: Hager.elsherif@hotmail.com
• Study Contact Backup: Name: Hend H Mohamed, Doctoral degree; Phone Number: +201226827307; Email: Hendhamdy110@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Modern university for technology and science
    • Contact: Hager Mahmoud Elsayed, Master Degree; Phone Number: 00201118602016; Email: hager.elsherif@hotmail.com
    • Contact: Naguib Salem Professor, Doctoral degree; Phone Number: 0020111806121
    • Contact: Hager Mahmoud Elsayed, Master degree
    • Contact: Ragia Mohamed kamal, Doctoral
    • Contact: Naglaa Fathy Awes, Doctoral
    • Contact: Hend Hamdy Mohamed, Doctoral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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) 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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
Experimental: Group B; Group B will receive Biodex balance training and short foot exercise.	Other: Short 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; Device: Biodex 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: MTI University
• Investigators: Principal Investigator: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 28, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Flat foot, Myoelectric activity, Biodex balance
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: BSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No