Balance and Gait in Diabetic Neuropathy

NCT05127538 | Completed

• 1 other identifier: KA21/317
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (6)

• Step Length

  Zebris Rehawalk (Zebris Medical GmbH, Germany) computerized gait evaluation system is used to assess the kinetic and kinematic analysis of the gait. The dynamic foot pressure distribution is analyzed with the pedobarography integrated into this system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  5 minutes

• Gait velocity

  Zebris Rehawalk (Zebris Medical GmbH, Germany) computerized gait evaluation system is used to assess the kinetic and kinematic analysis of the gait. The dynamic foot pressure distribution is analyzed with the pedobarography integrated into this system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  5 minutes

• cadance

  Zebris Rehawalk (Zebris Medical GmbH, Germany) computerized gait evaluation system is used to assess the kinetic and kinematic analysis of the gait. The dynamic foot pressure distribution is analyzed with the pedobarography integrated into this system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  5 minutes

• Foot pressure distribution

  Zebris Rehawalk (Zebris Medical GmbH, Germany) computerized gait evaluation system is used to assess the kinetic and kinematic analysis of the gait. The dynamic foot pressure distribution is analyzed with the pedobarography integrated into this system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  5 minutes

• static 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. The device gives the balance value as a printout by calculating the deviation rate of the individual from the target and the risk of falling forward, backward, and sideways.

  5 minutes

• 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 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. The device gives the balance value as a printout by calculating the deviation rate of the individual from the target and the risk of falling forward, backward, and sideways.

  5 minutes

Study Arms (3)

Individuals diagnosed with neuropathic pain due to type 2 diabetes

ACTIVE COMPARATOR

* Individuals between the ages of 40-65 * Individuals who take 4 points or more from the Douleur Neuropathique en 4 questions (DN4) questionnaire * Individuals who take 12 points or more from the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale

Diagnostic Test: Gait analysis; Diagnostic Test: Balance Assessment

Individuals with type 2 diabetes but no neuropathic pain

ACTIVE COMPARATOR

* Individuals between the ages of 40-65 * Individuals who take 4 points from the Douleur Neuropathique en 4 questions (DN4) questionnaire * Individuals who take 12 points from the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale

Diagnostic Test: Gait analysis; Diagnostic Test: Balance Assessment

Healthy control group

ACTIVE COMPARATOR

* Individuals between the ages of 40-65 * Individuals who have no pain (Taking 1 point or less according to the Visual Pain Scale)

Diagnostic Test: Gait analysis; Diagnostic Test: Balance Assessment

Interventions

Gait analysis DIAGNOSTIC_TEST

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.

Healthy control group; Individuals diagnosed with neuropathic pain due to type 2 diabetes; Individuals with type 2 diabetes but no neuropathic pain

Balance Assessment DIAGNOSTIC_TEST

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.

Healthy control group; Individuals diagnosed with neuropathic pain due to type 2 diabetes; Individuals with type 2 diabetes but no neuropathic pain

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 40-65
• Taking 4 points or more from the Douleur Neuropathique en 4 questions (DN4) questionnaire
• Taking 12 points or more from the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale
• Being between the ages of 40-65
• Taking below 4 points from the Douleur Neuropathique en 4 questions (DN4) questionnaire
• Taking below 12 points from the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale
• Being between the ages of 40-65
• Have no pain (Taking 1 point or less according to the Visual Pain Scale)

You may not qualify if:

• Having a complaint of pain from different etiology
• Having a diabetic foot ulcer
• Presence of neurological disease that may cause central neuropathic pain such as stroke, traumatic brain injury, multiple sclerosis
• Had orthopedic surgery in the last six months
• Having vision problems related to diabetes
• Had a diagnosis of vestibular disorders (Bening Paroxysmal Positional Vertigo, Meniere's Disease, etc.)
• Having chronic pain syndrome such as Fibromyalgia Syndrome

Sponsors & Collaborators

• Baskent University: lead
• Hacettepe University: collaborator

Study Sites (3)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

Fizyocare Rehabilitation Center

Ankara, Turkey (Türkiye)

Location

Related Publications (26)

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  PMID: 22371719 BACKGROUND

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• Huang CK, Shivaswamy V, Thaisetthawatkul P, Mack L, Stergiou N, Siu KC. An altered spatiotemporal gait adjustment during a virtual obstacle crossing task in patients with diabetic peripheral neuropathy. J Diabetes Complications. 2019 Feb;33(2):182-188. doi: 10.1016/j.jdiacomp.2018.10.005. Epub 2018 Oct 17.

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• Tapp RJ, Shaw JE, de Courten MP, Dunstan DW, Welborn TA, Zimmet PZ; AusDiab Study Group. Foot complications in Type 2 diabetes: an Australian population-based study. Diabet Med. 2003 Feb;20(2):105-13. doi: 10.1046/j.1464-5491.2003.00881.x.

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• Lafond D, Corriveau H, Prince F. Postural control mechanisms during quiet standing in patients with diabetic sensory neuropathy. Diabetes Care. 2004 Jan;27(1):173-8. doi: 10.2337/diacare.27.1.173.

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• Higgins DM, Heapy AA, Buta E, LaChappelle KM, Serowik KL, Czlapinski R, Kerns RD. A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain. J Health Psychol. 2022 Mar;27(3):649-662. doi: 10.1177/1359105320962262. Epub 2020 Oct 19.

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• Izgu N, Gok Metin Z, Karadas C, Ozdemir L, Metinarikan N, Corapcioglu D. Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue, and Quality of Life in Patients With Type 2 Diabetes: A Randomized Clinical Trial. J Nurs Scholarsh. 2020 Sep;52(5):476-487. doi: 10.1111/jnu.12580. Epub 2020 Jun 13.

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• Gok Metin Z, Arslan IE. Diabetic Peripheral Neuropathic Pain From the Perspective of Turkish Patients: A Qualitative Study. J Transcult Nurs. 2018 Nov;29(6):514-522. doi: 10.1177/1043659617753044. Epub 2018 Jan 17.

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• Allet L, Armand S, de Bie RA, Golay A, Pataky Z, Aminian K, de Bruin ED. Clinical factors associated with gait alterations in diabetic patients. Diabet Med. 2009 Oct;26(10):1003-9. doi: 10.1111/j.1464-5491.2009.02811.x.

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• Almurdhi MM, Brown SJ, Bowling FL, Boulton AJM, Jeziorska M, Malik RA, Reeves ND. Altered walking strategy and increased unsteadiness in participants with impaired glucose tolerance and Type 2 diabetes relates to small-fibre neuropathy but not vitamin D deficiency. Diabet Med. 2017 Jun;34(6):839-845. doi: 10.1111/dme.13316. Epub 2017 Feb 9.

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• Mustapa A, Justine M, Mohd Mustafah N, Jamil N, Manaf H. Postural Control and Gait Performance in the Diabetic Peripheral Neuropathy: A Systematic Review. Biomed Res Int. 2016;2016:9305025. doi: 10.1155/2016/9305025. Epub 2016 Jul 20.

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• Grewal GS, Sayeed R, Schwenk M, Bharara M, Menzies R, Talal TK, Armstrong DG, Najafi B. Balance rehabilitation: promoting the role of virtual reality in patients with diabetic peripheral neuropathy. J Am Podiatr Med Assoc. 2013 Nov-Dec;103(6):498-507. doi: 10.7547/1030498.

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MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Gait Disorders, Neurologic

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Ozlem Yuruk, Assoc.Prof

  Baskent University

  STUDY DIRECTOR

• Suleyman Korkusuz, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: December 10, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)