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

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise: 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.

Study summary

Diabetic peripheral neuropathy (DPN) is a common complication of both type 1 and type 2 diabetes. DPN is characterized by significant axonal degeneration and segmental demyelination that affect sensory and motor nerves. While various studies in the literature have examined the impact of plantar sensation on gait and balance parameters, no research has yet investigated the effects of foot sensory training on plantar sensation, functional performance, balance, gait, and kinesiophobia in individuals with type 2 diabetes and neuropathy. To contribute to the existing literature, 40 individuals with type 2 diabetes and neuropathy-recruited from the Endocrinology and Metabolism Diseases Outpatient Clinic at Dursun Odabaş Medical Center-will be enrolled in this randomized controlled trial. Following the provision of diabetic foot education to all participants, they will be assigned to either an experimental group (n=20) or a control group (n=20) using a sequential randomization method. The experimental group will receive foot sensory training, while the control group will receive no intervention; however, upon completion of the study, sensory training will be offered to any participants in the control group who request it. All participants will be assessed at the beginning and end of the training period in terms of foot sensation, functional performance, balance, gait, and kinesiophobia. Foot sensation will be evaluated using light touch, two-point discrimination, and vibration tests. Functional performance will be assessed via the "Timed Up and Go" (TUG) test and a timed stair-climbing (ascending and descending) test. Kinesiophobia will be measured using the Tampa Scale for Kinesiophobia. Balance will be assessed using the single-leg stance test and the Y-balance test, while gait will be analyzed via software based on the Kinect V2 camera. Physical activity levels will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Data obtained from the study will be analyzed using SPSS (Statistical Package for the Social Sciences) software. Data values will be expressed as percentages, means, and standard deviations; for comparison tests, the significance level (p) will be set at 0.05.

Eligibility

Primary outcome measure(s)

• Tampa Kinesiophobia Scale — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  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. Total scores range from 17 to 68, with higher scores indicating a higher level of kinesiophobia (worse outcome). The Turkish version of the scale has been shown to be valid and reliable.
• Evaluation of Light touch sense — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  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.
• Timed Up and Go Test — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  Functional mobility will be assessed using the Timed Up and Go (TUG) Test, which evaluates functional mobility parameters such as walking speed, postural control and balance. Participants will stand up from a standard armless chair, walk 3 meters, turn, walk back and sit down again. After one practice trial, the test will be performed three times and the mean of the three trials will be used for analysis. Timing will start when the participant stands up from the chair and stop when the participant sits back down. The result is recorded as the time to complete the test in seconds; longer times indicate worse functional mobility. The test will be performed at baseline and at the end of the 6-week intervention period.
• Single Leg StanceTest — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  Statik denge, Tek Ayak Üzerinde Durma Testi (Single Leg Stance Test) kullanılarak değerlendirilecektir. Katılımcılardan, test edilmeyen bacaklarının dizini 90° bükerek, dengelerini bozmadan tek ayak üzerinde durmaları istenecektir. Ayak yerden kalktığı anda kronometre başlatılacaktır. Test, hem sağ hem de sol alt ekstremite için 3 kez uygulanacak ve her bir taraf için üç denemenin ortalaması alınacaktır. Sonuç, katılımcının tek ayak üzerindeki pozisyonunu koruduğu süre (saniye cinsinden) olarak kaydedilir; daha uzun süreler, daha iyi bir statik dengeye işaret eder. Test, başlangıçta ve 6 haftalık müdahale döneminin sonunda gerçekleştirilecektir.
• Gait Analysis — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  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.
• Evaluation of vibration sense — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  Vibration sense will be evaluated using a 128-Hz tuning fork. Measurements will be performed with the participant in the supine position with eyes closed, at the first metatarsal head and the medial malleolus. The vibrating tuning fork will be placed on each point and the time (in seconds) until the participant no longer perceives the vibration will be recorded. Each measurement will be repeated three times and the mean will be used for analysis. Longer times indicate better vibration sense. The test will be performed at baseline and at the end of the 6-week intervention period.
• Evaluation of Two-point discrimination sense — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  Two-point discrimination will be assessed using an esthesiometer at three reference points on the sole of the foot: the transmetatarsal region, the midpoint of the midfoot and the midpoint of the heel. The esthesiometer will be applied sequentially to each reference point, starting from the maximum distance and gradually decreasing the distance between the two tips. The smallest distance (in millimeters) at which the participant can still distinguish two separate points, before perceiving them as a single point, will be recorded. Lower values indicate better two-point discrimination. The test will be performed at baseline and at the end of the 6-week intervention period.
• Stair Climb Test — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  Functional mobility will be assessed using the Stair Climb Test, which evaluates components of functional mobility such as strength, speed and agility. Participants will be asked to ascend a 10-step staircase, turn around at the top without pausing, descend and return to the starting point. Use of the handrail will be permitted. After one practice trial, the test will be performed three times and the mean of the three trials will be used for analysis. Timing will start with the "go" command and stop when both feet touch the floor at the end of the descent. The result is recorded as the time in seconds; shorter times indicate better functional mobility. The test will be performed at baseline and at the end of the 6-week intervention period.
• Y Balance test — Baseline (pre-intervention) and at 6 weeks (post-intervention)
  Dynamic balance will be assessed using the Y Balance Test. Participants will stand on one leg at the center of the Y-shaped apparatus with hands on the hips and reach as far as possible with the free leg in the anterior, posteromedial and posterolateral directions without losing balance. Three trials will be performed in each direction, and the mean reach distance (cm) will be calculated. The test will be applied to both lower extremities. Lower limb length will be measured in the supine position from the anterior superior iliac spine to the most distal point of the medial malleolus. Reach distances will be normalized to limb length using the formula: (reach distance / limb length) × 100. A composite score will be calculated as: (anterior + posteromedial + posterolateral reach) / (3 × limb length) × 100. Results are expressed as a percentage of limb length; higher scores indicate better dynamic balance. The test will be performed at baseline and at the end of the 6-week intervention p

Trial sites (1)

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