Effect of Sensory Training on Functional Performance, Balance, Gait in Type 2 Diabetic Individuals With Neuropathy

NCT06979401 | Not Yet Recruiting DMC

• 1 other identifier: 2025/7046
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic peripheral neuropathy (DPN) is a common complication of type 1 and type 2 diabetes. DPN is characterized by significant axonal degeneration and segmental demyelination affecting sensory and motor nerves. The effect of foot sole sensation on gait and balance parameters has been reported in various studies in the literature, however, no study has been found examining the effect of foot sensory training on plantar sensation, functional performance, balance, gait and kinesiophobia in type 2 diabetic individuals with neuropathy. In order to contribute to the literature, 40 type 2 diabetic individuals with neuropathy who applied to the Turgut Ozal Medical Center Endocrinology and Metabolic Diseases Polyclinic will be included in this randomized controlled study. After diabetic foot training is given to all participants, an experimental (20) and a control (20) group will be formed with a sequential random method. Foot sensory training will be given to the experimental group, while no intervention will be made to the control group, and sensory training will be given to the participants who wish after the study is completed. All participants will be evaluated for subscapular sense, functional performance, balance, walking and kinesiophobia at the beginning and end of the training. Subscapular sense will be evaluated with light touch, two-point discrimination and vibration tests. Functional performance evaluation will be made with timed up and go test and timed stair ascent-descend test. Kinesiophobia will be analyzed with Tampa Kinesiophobia Scale, Balance; One-Legged Stand Test and Y balance tests and walking will be analyzed with Kinect V2 camera based software. Physical activity levels will be evaluated with International Physical Activity Questionnaire-Short Form. The data taken into the research will be analyzed with SPSS (Statistical Program in Social Sciences) program. The values belonging to the data will be expressed with percentage, mean and standard deviation, and the significance level (p) will be taken as 0.05 for comparison tests.

Conditions

Diabetes; Type 2 Diabetes; Diabetic Peripheral Neuropathy; Kinesiophobia; Balance; Functional Performance; Gait Analysis; Plantar Sensation

Keywords

balance; Plantar Sensation; type 2 diabetes; gait; kinesiophobia; functional performance; diabetic peripheral neurophaty

Outcome Measures

Primary Outcomes (9)

• Tampa Kinesiophobia Scale

  Tampa Kinesiophobia Scale is a Likert-type scale consisting of 17 questions. Turkish validity and reliability of the scale has been performed. It is used to determine the level of kinesiophobia of individuals.

  6 week

• Evaluation of Light touch sense

  Light touch sensation will be evaluated using Semmes-Weinstein Monofilaments with reference to the metatarsal head, 5th metatarsal head and heel midpoint. The monofilament will be held for 1-1.5 seconds at each reference point and the patient will be asked to say "yes" when they feel the filament. 3 measurements will be taken from each point and 10 seconds will be allowed between measurements. The value of the filament felt by the patient will be recorded as a score.

  6 week

• Timed Up and Go Test

  The timed get up and go test was developed to assess functional mobility parameters such as walking speed, postural control and balance. This test involves standing up from a normal-sized chair without arms, walking three meters, then returning and sitting back down on the chair. During the test, the individual will be asked to take a trial walk and then carefully perform the test three times. The average of these three tests will be taken as the basis. Walking speed will be recorded in seconds. The time will be started when the individual stands up from the chair. It will be stopped and recorded when the individual sits back in the chair.

  6 week

• Single Leg StanceTest

  The Single Leg StanceTest will be used to assess static balance. For this test, participants will be asked to stand without falling for 30 s with the non-evaluated side knee in 90° flexion. The stopwatch will be started as soon as the foot leaves the ground. Each fall to maintain balance will be recorded as a score. The test will be repeated 3 times for the right and left lower extremities and averaged.

  6 week

• Gait Analysis

  The gait analysis of the participants will be evaluated with a Kinect V2 camera-based software. This software is developed in MATLAB environment and identifies joint positions by processing depth images. In the developed software, the joint position is first determined for a pixel in the depth images and the accuracy level is calculated for each pixel. A validation study of the gait analysis of the Kinect camera system was conducted by Baldewijns et al.

  6 week

• Evaluation of vibration sense

  The sense of vibration will be evaluated using a 128-Hz frequency diapason. Measurements will be made with the patient in the supine position with eyes closed, with reference to the 1st metatarsal head and medial malleolus. Each measurement point will be repeated three times and the average will be recorded in seconds.

  6 week

• Evaluation of Two-point discrimination sense

  Two-point discrimination will be assessed using an esthesiometer. In the study, trans-metatarsal, heel midpoint and midfoot midpoint will be taken as reference. The esthesiometer will be touched sequentially to the reference points on the sole of the participant's foot. Measurement will start from the maximum distance and continue by decreasing the range. The distance at which the patient perceives one point instead of two points at the specified reference points will be recorded in millimeters.

  6 week

• Stair Climb Test

  The stair climb test was developed to assess functional mobility content such as strength, speed and maneuverability. The test consists of the participant climbing the steps of the staircase and descending back to the starting point from the 10th step. They are free to hold on the edge of the ladder. At the beginning of the test, the participants will be asked to climb the ladder with a total of 10 steps and without waiting, turn back, descend the ladder and return to the starting point. During the test, the individual will be asked to perform a trial test. They will then be asked to repeat the test three times. These three tests will be averaged. Starting with the go command, the time in seconds will be recorded until both feet land on the floor on the return.

  6 week

• Y Balance test

  The Y Balance Test will be used for the assessment of dynamic balance. After the individual is placed in the center of the Y-shaped apparatus with hands on the waist, they will be asked to reach in the anterior, posteromedial and posterolateral directions with the other leg with one leg fixed. While extending the moving foot along the desired vector throughout the measurement, they will be asked to touch the farthest point they can reach without losing their balance in a one-leg stance and the distance of this point to the center will be measured. Reaching will be asked 3 times in each direction and then the average of the reaching distances will be taken and recorded in centimeters. The test will be applied to both extremities.

  6 week

Study Arms (2)

intervention

EXPERIMENTAL

After obtaining informed consent to participate in the study, all participants will be evaluated by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the intervention group and the control group will be formed by a sequential random method. Foot sensory training will be applied to the intervention group and no intervention will be made to the control group. However, after the study is completed, sensory training will be provided to the participants in the control group who wish to do so. Foot sensory training will be performed by the researcher physiotherapist. Foot sensory training sessions will be planned for 6 weeks, 3 days a week. An initial assessment will be made before the sessions begin and a final assessment will be made after the 6-week foot sensory training program.

Other: Exercise

Control

NO INTERVENTION

Individuals who agree to participate in the study and meet the inclusion criteria will be asked for written consent with a consent form. The researcher will meet with the participants one-on-one and provide information about the purpose of the study. The pre-test data of the study will be collected by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the intervention group and the control group will be formed with a sequential random method. Individuals in the control group will not receive any intervention and will continue their standard drug treatments for diabetes. Post-test data will be collected after the 6-week sensory training given to the intervention group. They will only complete the pre-test and post-test and will not participate in sensory training. Their data will be used for comparison purposes to evaluate the effectiveness of the intervention.

Interventions

Exercise OTHER

After obtaining informed consent to participate in the study, all participants will be evaluated by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the experimental group and the control group will be formed by a sequential random method. Foot sensory training will be applied to the experimental group and no intervention will be made to the control group. However, after the study is completed, sensory training will be provided to the participants in the control group who wish to do so. Foot sensory training will be performed by the researcher physiotherapist. Foot sensory training sessions will be planned for 6 weeks, 3 days a week. An initial assessment will be made before the sessions begin and a final assessment will be made after the 6-week foot sensory training program.

Also known as: foot sensory training

intervention

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 35-65 years old
• Being diagnosed with type 2 diabetes
• Having achieved glycemic control
• Having given less than 8 correct answers in the Semmes-Weinstein Monofilament test performed with a 5.07 monofilament
• Getting a Neuropathy Disability Score of 3 and above
• Being willing to participate in the study
• Being literate

You may not qualify if:

• Having a neurological or orthopedic comorbidity
• Having a respiratory disease such as uncontrolled COPD or asthma
• Having active lower extremity ulceration
• Using medications known to affect the postural control system such as benzodiazepines
• Having nephropathy, retinopathy and diabetic arthritis at a level that may affect mobility in addition to neuropathy
• Using a walking aid
• Body Mass Index \>30
• Having communication problems
• Not participating in at least 3 consecutive exercise sessions
• Not participating in more than 30% of each session

Sponsors & Collaborators

• Aylin DEMİR: lead

Study Sites (1)

İnonu University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Kinesiophobia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Aylin Demir, research assistant

CONTACT

+904382126213; ayln.dmir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RESEARCH ASSISTANT

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 19, 2025
• Study Start: June 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: December 15, 2025
• Last Updated: May 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)