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

Phase 1

Not yet recruiting

• Conditions: Hallux Valgus
• Interventions: Procedure: Scarf osteotomy for Hallux Valgus deformity

• Registration Number: NCT05210127
• Lead Sponsor: Józef Piłsudski University of Physical Education

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Study Start: 2022-06-01
• Primary Completion: 2023-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
After Scarf Osteotomy Group	Scarf osteotomy for Hallux Valgus deformity	30 participants after surgery
Without Scarf Osteotomy Group	Scarf osteotomy for Hallux Valgus deformity	30 participants without surgery

Primary Outcome Measures

Name	Time	Method
Zebris Medical System	8 weeks	The plantar pressure distribution measurement systems
EMG test	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)	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	8 weeks	Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint
Podoscope test	8 weeks	A diagnostic device that allows the assessment of the sole of the foot while standing