Clinical trial NCT05000398: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise
Hallux Valgus
Keywords: hallux valgus
exercise
home program
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: hallux valgus angle
timeFrame: Change from Baseline and at the end of 8 weeks
Secondary outcomes:
measure: hallux valgus pain
timeFrame: Change from Baseline and at the end of 8 weeks
measure: Functional Status
timeFrame: Change from Baseline and at the end of 8 weeks
measure: life quality
timeFrame: Change from Baseline and at the end of 8 weeks
measure: kinesiophobia
timeFrame: Change from Baseline and at the end of 8 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Merve Betül Öztarsu
Study officials:
affiliation: Eastern Mediterranean University
name: Sevim Öksüz, assist.prof.
role: STUDY_DIRECTOR
References: