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

September 18, 2024 updated by: Hager Mahmoud mohamed elsayed, Cairo University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Modern university for technology and science
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle myoelectric activity
Time Frame: 4 weeks
myoelectric activity of paraspinal muscles measured by surface electromygraphy
4 weeks
Foot print pressure
Time Frame: 4 weeks
Using myopressure force platform to measure average peak planter pressure
4 weeks
Dynamic balance
Time Frame: 4 weeks
Biodex balance system will be used to assess balance before and after treatment
4 weeks
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
4 weeks
Pain severity
Time Frame: 4 weeks
Evaluation of lower back pain severity by using visual analogue scale
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MTI University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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