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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
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, core foot system, rehabilitation protocol

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    December 1, 2021
    Last Updated
    January 13, 2022
    Sponsor
    Józef Piłsudski University of Physical Education
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    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

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

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