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Not yet recruitingNCT05210127Updated Jan 27, 2022

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

A Phase 1 interventional study of Scarf osteotomy for Hallux Valgus deformity in Hallux Valgus, sponsored by Józef Piłsudski University of Physical Education. Not yet recruiting. Open to female participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-01-27.

Sponsored by Józef Piłsudski University of Physical Education · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2023, 3 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
Female
01

Study 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?
02

Conditions studied

  • Hallux Valgus

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Keywords

  • hallux valgus
  • core foot system
  • rehabilitation protocol
03

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Józef Piłsudski University of Physical Education is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hallux valgus deformity
  • surgical procedure
  • voluntary consent to the study

Exclusion criteria

Exclusion Criteria:

  • lack of consent to research
  • other deformation and operations of the foot
  • pain after the surgery which prevents experimental procedure
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    After Scarf Osteotomy Group

    30 participants after surgery

    Procedure: Scarf osteotomy for Hallux Valgus deformity

  • Experimental
    Without Scarf Osteotomy Group

    30 participants without surgery

    Procedure: Scarf osteotomy for Hallux Valgus deformity

Interventions

  • ProcedureScarf 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

06

What researchers measure

Primary outcomes

  1. American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint

    Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint

    Time frame: 8 weeks

  2. 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)

    Time frame: 8 weeks

  3. Zebris Medical System

    The plantar pressure distribution measurement systems

    Time frame: 8 weeks

  4. EMG test

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

    Time frame: 8 weeks

  5. Podoscope test

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

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2022; primary completion for Jan 2023, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2021
First posted
Jan 27, 2022
StartEst.
Jun 1, 2022
Primary completionEst.
Jan 1, 2023
CompletionEst.
Jun 1, 2025
Last update
Jan 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05210127
Lead sponsor
Józef Piłsudski University of Physical Education
Responsible party
Sponsor
First posted
Jan 27, 2022
Start date
Jun 1, 2022 (estimated)
Primary completion
Jan 1, 2023 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jan 27, 2022

Study contacts

Mateusz Baran
Contact
mateusz.baran.93@wp.pl
500220003
Mateusz Baran
Contact
mb683@stud.awf.edu.pl
500220003

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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