Balance and Gait in Diabetic Neuropathy

Summary

The aim of the study is to evaluate the effects of neuropathic pain due to type 2 diabetes on balance and gait. The study is a prospective controlled study. The study is being carried out at the Physical Therapy and Rehabilitation Center Gait Analysis Laboratory Unit in Turkey.

Individuals diagnosed with neuropathic pain due to Type 2 Diabetes and individuals with diabetes without neuropathic pain are included in the study by clinical examination and tests by a physician. At the same time, healthy individuals are participating as the control group.

There will 3 groups in the study :

Group 1: Individuals diagnosed with neuropathic pain due to type 2 diabetes (n=14) Group 2: Individuals with type 2 diabetes but no neuropathic pain (n=14) Group 3: Healthy control group (n=14)

Assessments:

Individual and clinical characteristics of individuals: age, gender, height, body weight, marital status, education level, duration of complaints, and dominant side.

Douleur Neuropathique en 4 questions (DN4) Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Questionnaire Visual Analog Scale (VAS) Gait analysis Static and dynamic balance

The data will be analyzed using the statistical program for social sciences (SPSS) version 21.0 (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp.). The data will be expressed as mean standard deviation (X±SD) and number (n%). The homogeneity of the groups will be evaluated with the Levene Test. Balance, plantar pressure, and walking values between the groups will be compared using the Kruskal Wallis Test. All the statistical analyses will be set a priori at an alpha level of p\<0.05.

Conditions

• Neuropathy, Diabetic
• Pain, Neuropathic
• Gait Disorder, Sensorimotor

Interventions

DIAGNOSTIC_TEST

Gait analysis

Gait analysis Zebris Rehawalk (Zebris Medical GmbH, Germany) computerized gait evaluation system is used to assess the kinetic and kinematic analysis of the gait. The system consists of a treadmill and a computer. For gait assessment, patients walk at their preferred comfortable walking speed.

DIAGNOSTIC_TEST

Balance Assessment

Static and dynamic balance Static and dynamic balance and stability limit values are evaluated with the E-LINK FP3 Force Plate (Biometrics Ltd, United Kingdom) system. The device consists of a computer and a platform on which individuals can place their feet. For static balance measurement, individuals are asked to place their feet on the marked places on the platform and hold an object on the computer screen at a fixed point for 30 seconds without support from their hands. For dynamic balance, individuals need to follow a moving object on the computer screen for 30 seconds by putting their body weight forward, backward, and sideways with their feet.

Sponsors & Collaborators

• Hacettepe University

  collaborator OTHER

• Baskent University

  lead OTHER

Principal Investigators

• Ozlem Yuruk, Assoc.Prof · Baskent University

• Suleyman Korkusuz, MSc · Hacettepe University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-10

Primary Completion

2022-01-20

Completion

2022-01-20

Countries

• Turkey (Türkiye)

Study Locations