Assessment of Balance and Gait in Patients With Diabetic Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baskent University
- Enrollment
- 42
- Locations
- 5
- Primary Endpoint
- Gait velocity
Study Overview
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.
Detailed Description
Diabetes is a metabolic disorder characterized by chronic hyperglycemia due to a deficiency in the insulin hormone. The most common symptoms of type 2 diabetes include diabetic peripheral neuropathy, which results in hyperglycemia, polyuria, muscle weakness, numbness, and tingling sensations in the extremities.
Diabetic peripheral neuropathy, one of the most common long-term complications of diabetes, is characterized by damage to sensory and motor nerve fibers caused by uncontrolled hyperglycemia, seen in approximately 50% of diabetic patients. In diabetic peripheral neuropathy, there is an impairment in the conduction of afferent and efferent fibers. Thus, decreased muscle strength, weakening in postural control, and tactile sensation loss occurs compared to healthy individuals.
Pain is one of the most common problems in diabetic peripheral neuropathy. Pain and paresthesia increase especially at night in the lower extremities. Diabetic neuropathic pain results in different physical problems such as the increased risk of falling, loss of balance and coordination while standing or walking, susceptibility to injuries due to sensory loss, sleep disorders, and fatigue.
Gait disorders are one of the complications seen in diabetic peripheral neuropathy. Neuromuscular damage due to neuropathy causes alterations in the biomechanics of the lower extremities, and thus, deterioration in the time-distance characteristics of gait such as stride length, stride width, double and single support period.
Studies report that increased dynamic mediolateral and anteroposterior swing cause postural instability. Falls caused by lack of postural control and gait disorders are 15 times more common in patients with diabetic peripheral neuropathy than in healthy individuals. Therefore, it is necessary to evaluate the balance and calculate the risk of falling.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion criteria for individuals with neuropathic pain due to type 2 diabetes:
- •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
- •Inclusion criteria for individuals with type 2 diabetes but no neuropathic pain:
- •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
- •Inclusion criteria of healthy individuals in the study:
- •Being between the ages of 40-65
- •Have no pain (Taking 1 point or less according to the Visual Pain Scale)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Gait velocity
Time Frame: 5 minutes
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.
cadance
Time Frame: 5 minutes
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.
Dynamic Balance
Time Frame: 5 minutes
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.
Foot pressure distribution
Time Frame: 5 minutes
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.
static balance
Time Frame: 5 minutes
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.
Step Length
Time Frame: 5 minutes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ozlem Yuruk
Assoc. Prof.
Baskent University