NCT05000398

Brief Summary

The aim of our study is to compare the effects of progressive exercise therapy, administered as a home program under the supervision of a physiotherapist, on adduction angle, pain, functional status, quality of life, and kinesiophobia in individuals aged 18-64 years with a hallux valgus angle of 15-40 degrees (mild-moderate).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 8, 2021

Last Update Submit

August 8, 2021

Conditions

Keywords

hallux valgusexercisehome program

Outcome Measures

Primary Outcomes (1)

  • hallux valgus angle

    The hallux valgus angle will be measured with a goniometer at the beginning and end of the treatment.

    Change from Baseline and at the end of 8 weeks

Secondary Outcomes (4)

  • hallux valgus pain

    Change from Baseline and at the end of 8 weeks

  • Functional Status

    Change from Baseline and at the end of 8 weeks

  • life quality

    Change from Baseline and at the end of 8 weeks

  • kinesiophobia

    Change from Baseline and at the end of 8 weeks

Study Arms (2)

exercise with a physiotherapist

ACTIVE COMPARATOR

Participants will exercise with a physiotherapist. 4 times a week for 8 weeks

Other: Stretching the intrinsic musclesOther: Thumb Abduction with MTF Joint TractionOther: Thumb active extension exerciseOther: Toe spread outOther: Short footOther: Heel riseOther: Towel toe curlOther: Gastrocnemius active static stretching exerciseOther: Plantar fascia and gastrocnemius stretching exercise on step

home program

EXPERIMENTAL

The same exercises will be given to the participants as brochures. 4 times a week for 8 weeks

Other: Stretching the intrinsic musclesOther: Thumb Abduction with MTF Joint TractionOther: Thumb active extension exerciseOther: Toe spread outOther: Short footOther: Heel riseOther: Towel toe curlOther: Gastrocnemius active static stretching exerciseOther: Plantar fascia and gastrocnemius stretching exercise on step

Interventions

Participants will be asked to dorsiflex the foot and stretch for 30 seconds. It will be done with 5 repetitions.

exercise with a physiotherapisthome program

participants will be held for 30 seconds by passively abducting the thumb within the limits of pain, and will be applied with 5 repetitions.

exercise with a physiotherapisthome program

An elastic band will be placed around the thumb, stretching enough to ensure proper alignment of the thumb and passively correct the position. It will be desired to move the feet away from each other without moving the heels from the ground and the extension movement of the thumbs.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.

exercise with a physiotherapisthome program

In the first stage, active finger extension and abduction will be requested while the heel and metatarsal heads are in contact with the ground. In the second stage, while the other fingers are in extension, the smallest finger will be brought laterally and flexed to contact the ground. In the third stage, while in the second stage position, the thumb will be brought into abduction and flexion slowly and contact with the ground will be requested. These 3 phases will be repeated sequentially.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.

exercise with a physiotherapisthome program

While standing , the medial arch will be raised by trying to bring the metatarsal heads closer to the heel . The patient will be asked to move the big toe closer to the heel without bending the toes and without lifting the heel off the ground.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.

exercise with a physiotherapisthome program

After taking a 5 cm high tape measure against the wall, the person will be asked to stand up on her heel by at least 5 cm.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.

exercise with a physiotherapisthome program

Patients will be asked to place their feet on the edge of the towel on the floor. An elastic band will be placed around the thumb, stretching enough to ensure proper alignment of the thumb and passively correct the position. Next, they will be asked to grasp the towel with their fingers, flexing their toes, and forcefully dragging them under their feet.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.

exercise with a physiotherapisthome program

The patient will be placed on the wall at eye level, 50 centimeters away from the wall. The leg that is desired to be stretched will be brought back, while the knee is straight, it will be requested to flex the front leg. During the test, it will be requested that the back heel does not rise from the ground and wait 30 seconds. 5 repetitions to be done

exercise with a physiotherapisthome program

The patient will be asked to place both feet on the step and slowly stretch the heel downwards until a stretch is felt in the arch of the foot and wait 30 seconds. 5 repetitions will be done

exercise with a physiotherapisthome program

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer individuals between the ages of 18-64
  • Mild to moderate (15-40 degrees) hallux valgus
  • Bilateral hallux valgus
  • Have not received physical therapy for hallux valgus in the last 6 months,
  • Individuals who did not use orthotic devices or dynamic splints for the treatment of hallux valgus will be included in the study.

You may not qualify if:

  • HVA ≥ 45°
  • Rjjit hallux valgus deformity (in cases where the hallux cannot be brought to its normal position manually)
  • Obesity (BMI\>30 kg/m2)
  • Systemic disease and inflammatory arthritis (rheumatoid arthritis, systemic lupus, diabetes mellitus)
  • Neurological disease (eg: neuropathy)
  • Vestibular disorder that may affect balance
  • History of standing trauma, fracture of the metatarophalangeal joint,
  • He has undergone foot-ankle surgery,
  • Using NSAIDs or analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Betül Öztarsu

Famagusta, 99628, Cyprus

RECRUITING

MeSH Terms

Conditions

Motor ActivityHallux Valgus

Condition Hierarchy (Ancestors)

BehaviorFoot DeformitiesMusculoskeletal Diseases

Study Officials

  • Sevim Öksüz, assist.prof.

    Eastern Mediterranean University

    STUDY DIRECTOR

Central Study Contacts

Merve Betül Öztarsu

CONTACT

Sevim Öksüz, assist. prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

August 8, 2021

First Posted

August 11, 2021

Study Start

May 24, 2021

Primary Completion

August 16, 2021

Study Completion

September 1, 2021

Last Updated

August 11, 2021

Record last verified: 2021-08

Locations