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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05210127
• Other study ID #: SKE 01-42/2021
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2021
• Source: Józef Pilsudski University of Physical Education
• Contact: Mateusz Baran
• Phone: 500220003
• Email: mateusz.baran.93[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

Outcome

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