Effects of Plantar Sensory Training in Individuals With Hallux Valgus.

NCT ID: NCT05344755

Last Updated: 2023-09-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-11-15

Brief Summary

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

Hallux valgus is a forefoot deformity with a high prevalence, which can progress to lateral deviation of the big toe, medial deviation of the first metatarsal, and subluxation of the first metatarsophalangeal joint in the future. It has been reported in studies that changes in the load distribution of the foot in hallux valgus patients, hyperkeratosis, especially first-line pain, and sensory receptors on the sole of the foot may result in the effect of sensory receptors on the sole of the foot, and thus the balance may be negatively affected, poor postural stability and an increase in the risk of falling. It is thought that increased sensitivity to the senses coming from the feet with sensory training can improve the balance and reduce the risk of falling as a result of better perception of foot orientation and position.

Detailed Description

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

Achieving balance depends on the visual, vestibular and somatosensory systems working together and in interaction. One of the important components of the somatosensory system is the cutaneous receptors. Merkel discs, Paccini corpuscles, Meissner corpuscles and Ruffini endings are located on the plantar surface of the foot, which makes contact with the ground. Plantar cutaneous receptors are sensitive to pressure during ground contact and provide site-specific information for cortical mapping and may affect postural responses. It is recommended that sensory training of the sole of the foot, rough insoles and transcutaneous electrical stimulation applications should be added to rehabilitation in order to increase the afferent sensory feedback from the sole of the foot in patients with multiple sclerosis, starting from the early stages of the disease. It has been reported in studies that the sensory input of different foot regions has an important role in the transition and timing of the stance and swing phase in gait. It has been suggested that cutaneous reflexes in the foot can provide functional locomotion and modulation of lower extremity flexor and extensor muscle activity. It has been reported in studies that changes in the load distribution of the foot in hallux valgus patients, hyperkeratosis, especially first-line pain, and sensory receptors on the sole of the foot may result in the effect of sensory receptors on the sole of the foot, and thus the balance may be negatively affected, poor postural stability and an increase in the risk of falling. It is thought that increased sensitivity to the senses coming from the feet with sensory training can improve the balance and reduce the risk of falling as a result of better perception of foot orientation and position. Therefore, the aim of our study; It was determined as the examination of the effect of plantar sensory training on pain, foot posture, functional activities, gait and balance parameters in individuals with hallux valgus.

Conditions

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

Hallux Valgus Pain Balance; Distorted

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

SINGLE

Participants

Study Groups

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

Plantar Sensorial Training

In addition to hallux valgus mobilization, active thumb abduction, strengthening of the muscles around the feet, hallux valgus taping and hallux valgus night splint, sensory training (using deep plantar massage, brushing, dipping techniques) will be performed.

Group Type EXPERIMENTAL

Plantar Sensorial Training

Intervention Type OTHER

In addition to the routine treatment, plantar sensorial training will be added.

Control Group

Routine hallux valgus physiotherapy approaches such as: hallux valgus mobilization, active thumb abduction, strengthening of the muscles around the feet, hallux valgus taping and hallux valgus night splint.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

Routine physiotherapy management of the Hallux valgus

Interventions

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

Plantar Sensorial Training

In addition to the routine treatment, plantar sensorial training will be added.

Intervention Type OTHER

Control Group

Routine physiotherapy management of the Hallux valgus

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Being diagnosed with mild or moderate hallux valgus;
* Volunteer to participate in the study

Exclusion Criteria

* Having pathologies that may cause sensory problems such as diabetes, multiple sclerosis, myelomeningocele, severe disc herniation,
* Having an orthopedic, rheumatological or neurological disease other than hallux valgus that will prevent participation in the exercise program
* Having previous foot surgery,
* Having a cooperation problem at a level that cannot understand and apply the exercises.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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

Elif Kırdı

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Gul Yazicioglu, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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

Turkey (Türkiye)

Other Identifiers

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

KA-20014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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