Balance and Gait in Diabetic Neuropathy (NCT05127538) | Clinical Trial Compass
CompletedNot Applicable
Balance and Gait in Diabetic Neuropathy
Turkey (Türkiye)42 participantsStarted 2021-12-10
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.