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

NCT ID: NCT05000398

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exercise Hallux Valgus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise with a physiotherapist

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

Group Type ACTIVE_COMPARATOR

Stretching the intrinsic muscles

Intervention Type OTHER

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

Thumb Abduction with MTF Joint Traction

Intervention Type OTHER

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

Thumb active extension exercise

Intervention Type OTHER

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.

Toe spread out

Intervention Type OTHER

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.

Short foot

Intervention Type OTHER

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.

Heel rise

Intervention Type OTHER

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.

Towel toe curl

Intervention Type OTHER

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.

Gastrocnemius active static stretching exercise

Intervention Type OTHER

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

Plantar fascia and gastrocnemius stretching exercise on step

Intervention Type OTHER

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

home program

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

Group Type EXPERIMENTAL

Stretching the intrinsic muscles

Intervention Type OTHER

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

Thumb Abduction with MTF Joint Traction

Intervention Type OTHER

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

Thumb active extension exercise

Intervention Type OTHER

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.

Toe spread out

Intervention Type OTHER

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.

Short foot

Intervention Type OTHER

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.

Heel rise

Intervention Type OTHER

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.

Towel toe curl

Intervention Type OTHER

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.

Gastrocnemius active static stretching exercise

Intervention Type OTHER

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

Plantar fascia and gastrocnemius stretching exercise on step

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stretching the intrinsic muscles

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

Intervention Type OTHER

Thumb Abduction with MTF Joint Traction

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

Intervention Type OTHER

Thumb active extension exercise

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.

Intervention Type OTHER

Toe spread out

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.

Intervention Type OTHER

Short foot

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.

Intervention Type OTHER

Heel rise

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.

Intervention Type OTHER

Towel toe curl

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.

Intervention Type OTHER

Gastrocnemius active static stretching exercise

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

Intervention Type OTHER

Plantar fascia and gastrocnemius stretching exercise on step

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merve Betül Öztarsu

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sevim Öksüz, assist.prof.

Role: STUDY_DIRECTOR

Eastern Mediterranean University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Merve Betül Öztarsu

Famagusta, , Cyprus

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Cyprus

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Merve Betül Öztarsu

Role: CONTACT

+903926303067

Sevim Öksüz, assist. prof.

Role: CONTACT

+903926302473

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zehra GÜÇHAN TOPCU

Role: primary

+903926303067 ext. 2496

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMerve

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.