Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure

January 13, 2022 updated by: Józef Piłsudski University of Physical Education

Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgery

The aim of the study is to identify the impact of CFS foot muscle training on time-space parameters, anthropometric parameters and bioelectrical activity (EMG) of the foot muscles during walking and to develop an algorithm for an effective therapeutic method in patients after hallux valgus correction. Achieving the purpose of the research will contribute to the answer to the following research questions:

  • Does the CFS therapy used significantly change the arch of the foot in HV patients compared to the control group?
  • Does the CFS therapy used significantly improve gait characteristics after HV surgery in relation to the control group?
  • Does muscle stimulation and the moment of their activation differ in groups in which different therapies have been used?
  • Will the results of the questionnaires and scale be significantly different in both groups?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

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 Backup

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

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • hallux valgus deformity
  • surgical procedure
  • voluntary consent to the study

Exclusion Criteria:

  • lack of consent to research
  • other deformation and operations of the foot
  • pain after the surgery which prevents experimental procedure

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: After Scarf Osteotomy Group
30 participants after surgery
Procedure: Scarf osteotomy for Hallux Valgus deformity
An experiment of foot muscle strength and activation, during gate phases after hallux valgus correction with the use of core foot system protocol
Experimental: Without Scarf Osteotomy Group
30 participants without surgery
Procedure: Scarf osteotomy for Hallux Valgus deformity
An experiment of foot muscle strength and activation, during gate phases after hallux valgus correction with the use of core foot system protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint
Time Frame: 8 weeks
Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint
8 weeks
The 36-Item Short Form Survey (SF-36)
Time Frame: 8 weeks
The SF-36 is often used as a measure of a person or population's quality of life (QOL)
8 weeks
Zebris Medical System
Time Frame: 8 weeks
The plantar pressure distribution measurement systems
8 weeks
EMG test
Time Frame: 8 weeks
Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle
8 weeks
Podoscope test
Time Frame: 8 weeks
A diagnostic device that allows the assessment of the sole of the foot while standing
8 weeks

Collaborators and Investigators

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

Sponsor

Józef Piłsudski University of Physical Education

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKE 01-42/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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