Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus

Not Applicable

• Conditions: Exercise; Hallux Valgus

• Registration Number: NCT05000398
• Lead Sponsor: Eastern Mediterranean University

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).

Detailed Description

According to the power analysis, 18 people will participate in the study. Individuals with halluk valgus pain, deformity angle, balance, functional capacity, functionality, quality of life and kinesiophobia will be evaluated.After the individuals are evaluated, they will be randomly divided into 2 groups as the exercise group and the home exercise group.

All patients will be instructed on wearing appropriate footwear (made of soft material, with a wide round toe, with a normal heel height between 1 inch and 1.5 inches (2.5-3.8 cm). In addition, in order to increase the awareness of the participants, they will be asked to focus on how muscle activation feels during exercise and they will be asked to perform this activation during daily living activities.

The exercise program to be given to both groups will be the same, and will be applied with bare feet 4 days a week for 8 weeks. The exercise program will be advanced as recommended in the literature and 30 seconds of rest will be given between sets.

After the evaluation, all exercises will be shown to the home exercise group and it will be ensured that they are applied correctly. An illustrated and narrative exercise program brochure containing information about exercise position, number of repetitions, contraction time, rest time between sets, frequency and exercise diary will be given to the patient for exercise follow-up.

At the end of 8 weeks, the evaluations will be repeated by the same physiotherapist.

Study Timeline

• Study Start: 2021-05-24
• Status Verified: 2021-08
• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-08
• Last Update Submitted: 2021-08-08
• Study First Posted: 2021-08-11
• Last Update Posted: 2021-08-11
• Primary Completion: 2021-08-16
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
hallux valgus angle	Change from Baseline and at the end of 8 weeks	The hallux valgus angle will be measured with a goniometer at the beginning and end of the treatment.

Secondary Outcome Measures

Name	Time	Method
hallux valgus pain	Change from Baseline and at the end of 8 weeks	Hallux valgus pain will be measured with the VAS scale at the beginning and end of treatment.
Functional Status	Change from Baseline and at the end of 8 weeks	Static Balance Evaluation: It will be evaluated with the one-leg standing test.Dynamic Balance Evaluation: It will be evaluated by Y balance test.Functional capacity: To be evaluated with a 6-minute walk test.Foot Function Index (FFI): This index measures pain, function and activity limitation
life quality	Change from Baseline and at the end of 8 weeks	The SF-36 quality of life questionnaire will be used to assess general health-related quality of life.
kinesiophobia	Change from Baseline and at the end of 8 weeks	The Tampa Kinesiophobia Scale will be used to measure the fear of movement or re-injury.

Trial Locations

Locations (1)

Merve Betül Öztarsu; 🇨🇾 Famagusta, Cyprus