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Clinical Trials/NCT05210127
NCT05210127
Not yet recruiting
Phase 1

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

Józef Piłsudski University of Physical Education0 sites60 target enrollmentJune 1, 2022
ConditionsHallux Valgus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hallux Valgus
Sponsor
Józef Piłsudski University of Physical Education
Enrollment
60
Primary Endpoint
Zebris Medical System
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

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?
Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
June 1, 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Józef Piłsudski University of Physical Education
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Zebris Medical System

Time Frame: 8 weeks

The plantar pressure distribution measurement systems

EMG test

Time Frame: 8 weeks

Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle

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)

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

Podoscope test

Time Frame: 8 weeks

A diagnostic device that allows the assessment of the sole of the foot while standing

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