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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorAylin DEMİR

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 week
2

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.

Time frame
6 week
3

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.

Time frame
6 week
4

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.

Time frame
6 week

Secondary outcomes

Other outcomes

Sponsors and contacts

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Aylin DEMİR

Lead sponsor

Inonu University

Sponsor institution

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