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Effects of Plantar Sensory Training in Individuals With Hallux Valgus.

Primary Purpose

Hallux Valgus, Pain, Balance; Distorted

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Plantar Sensorial Training
Control Group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, pain, sensory training, plantar sensory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plantar Sensorial Training

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Foot-Related pain assessment
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.

Secondary Outcome Measures

Change in Light touch sensation
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 in foot function
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 in lower extremity functional level
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 in gait parameters
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 in balance
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).

Full Information

First Posted
March 26, 2022
Last Updated
September 27, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05344755
Brief Title
Effects of Plantar Sensory Training in Individuals With Hallux Valgus.
Official Title
Investigation of the Effect of Plantar Sensory Training on Pain, Foot Posture, Functional Activities, Gait and Balance Parameters in Individuals With Hallux Valgus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Pain, Balance; Distorted
Keywords
hallux valgus, pain, sensory training, plantar sensory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plantar Sensorial Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Plantar Sensorial Training
Intervention Description
In addition to the routine treatment, plantar sensorial training will be added.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Routine physiotherapy management of the Hallux valgus
Primary Outcome Measure Information:
Title
Change in Foot-Related pain assessment
Description
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.
Time Frame
change from baseline pain severity at 6 weeks
Secondary Outcome Measure Information:
Title
Change in Light touch sensation
Description
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.
Time Frame
change from baseline light touch sensation at 6 weeks
Title
Change in foot function
Description
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.
Time Frame
change from baseline foot function at 6 weeks
Title
Change in lower extremity functional level
Description
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
Time Frame
change from baseline Lower extremity functional level at 6 weeks
Title
Change in gait parameters
Description
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
Time Frame
change from baseline temporo-spatial gait parameters at 6 weeks
Title
Change in balance
Description
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).
Time Frame
change from baseline postural sway and limits of stability at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gul Yazicioglu, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Plantar Sensory Training in Individuals With Hallux Valgus.

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