Effects of Plantar Sensory Training in Individuals With Hallux Valgus.

September 27, 2023 updated by: Elif Kırdı, Hacettepe University

Investigation of the Effect of Plantar Sensory Training on Pain, Foot Posture, Functional Activities, Gait and Balance Parameters in Individuals With Hallux Valgus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Plantar Sensorial Training
In addition to the routine treatment, plantar sensorial training will be added.
Active Comparator: 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.
Other: Control Group
Routine physiotherapy management of the Hallux valgus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Foot-Related pain assessment
Time Frame: change from baseline pain severity at 6 weeks
Visual Analogue Scale will be used to evaluate the pain severity of individuals. Participants will be asked to mark their pain at rest and activity on a horizontal line of 100 millimeters, with 100 indicating maximum pain and 0 indicating no pain.
change from baseline pain severity at 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Light touch sensation
Time Frame: change from baseline light touch sensation at 6 weeks
The light touch sense of the sole of the foot will be evaluated with the Semmes-Weinstein monofilament test. This test is widely used to evaluate light touch and pressure sense. The response to touch is tested with monofilaments of varying thickness and diameter, and the value that the patient feels is recorded.
change from baseline light touch sensation at 6 weeks
Change in foot function
Time Frame: change from baseline foot function at 6 weeks
The AOFAS Hallux-Metatarsophalangeal-Interphalangeal Scale created by the American Foot and Ankle Foundation (AOFAS) will also be used to evaluate foot function. In this scale, which is a 100-point scoring system that evaluates pain, function, and alignment, 90-100 points are excellent, 75-89 points are good, 50-74 points are good, and less than 50 points indicate poor status.
change from baseline foot function at 6 weeks
Change in lower extremity functional level
Time Frame: change from baseline Lower extremity functional level at 6 weeks
The Lower Extremity Functionality Scale (LEFS), which is used in individuals with lower extremity problems, will be used to classify the functional status of individuals. AEFS is a 5-point Likert scale consisting of 20 questions. High scores in this scale, which has been adapted to Turkish and whose scoring ranges from 0 to 80, represent a better functional situation
change from baseline Lower extremity functional level at 6 weeks
Change in gait parameters
Time Frame: change from baseline temporo-spatial gait parameters at 6 weeks
Individuals' gait will be assessed using the GAITRite® computerized walking path (CIR System INC. Clifton, NJ 07012). Data from the system, which has 18,432 sensors, is obtained by pressure-activated sensors at a rate of 60-120 Hz. In order to eliminate the learning effect, the subjects will be asked to walk at the pace they choose after three attempts are made. Rest breaks will be given between assessments and the average of three repetitions of the walk will be recorded
change from baseline temporo-spatial gait parameters at 6 weeks
Change in balance
Time Frame: change from baseline postural sway and limits of stability at 6 weeks
Stability limits of individuals will be evaluated with Bertec Balance Check Trainer. Participants will be asked to lie on this device in the front, back, right and left directions as far as they can go without losing their balance and without lifting the soles of their feet off the platform, and the measurement results will be recorded by the system. Also, Postural sway of individuals will be evaluated and recorded with the Bertec Balance Check Trainer. It will be evaluated in four different conditions: flat ground with eyes open, flat ground with eyes closed, soft ground with eyes open and soft ground with eyes closed. Individuals will be asked to stand upright for 10 seconds for each situation, and the results will be recorded in centimeters by the system (Force plate AM, Bertec, Columbus, OH).
change from baseline postural sway and limits of stability at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gul Yazicioglu, Prof, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-20014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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