Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure
Primary Purpose
Hallux Valgus
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Scarf osteotomy for Hallux Valgus deformity
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, core foot system, rehabilitation protocol
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
After Scarf Osteotomy Group
Without Scarf Osteotomy Group
Arm Description
30 participants after surgery
30 participants without surgery
Outcomes
Primary Outcome Measures
American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint
Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint
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)
Zebris Medical System
The plantar pressure distribution measurement systems
EMG test
Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle
Podoscope test
A diagnostic device that allows the assessment of the sole of the foot while standing
Secondary Outcome Measures
Full Information
NCT ID
NCT05210127
First Posted
December 1, 2021
Last Updated
January 13, 2022
Sponsor
Józef Piłsudski University of Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT05210127
Brief Title
Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure
Official Title
Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Józef Piłsudski University of Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
hallux valgus, core foot system, rehabilitation protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
After Scarf Osteotomy Group
Arm Type
Experimental
Arm Description
30 participants after surgery
Arm Title
Without Scarf Osteotomy Group
Arm Type
Experimental
Arm Description
30 participants without surgery
Intervention Type
Procedure
Intervention Name(s)
Scarf osteotomy for Hallux Valgus deformity
Intervention Description
An experiment of foot muscle strength and activation, during gate phases after hallux valgus correction with the use of core foot system protocol
Primary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint
Description
Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint
Time Frame
8 weeks
Title
The 36-Item Short Form Survey (SF-36)
Description
The SF-36 is often used as a measure of a person or population's quality of life (QOL)
Time Frame
8 weeks
Title
Zebris Medical System
Description
The plantar pressure distribution measurement systems
Time Frame
8 weeks
Title
EMG test
Description
Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle
Time Frame
8 weeks
Title
Podoscope test
Description
A diagnostic device that allows the assessment of the sole of the foot while standing
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mateusz Baran
Phone
500220003
Email
mateusz.baran.93@wp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Mateusz Baran
Phone
500220003
Email
mb683@stud.awf.edu.pl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure
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