Neuropathy, DiabeticNCT05127538
Balance and Gait in Diabetic Neuropathy
A study testing Gait analysis and Balance Assessment in people with Neuropathy, Diabetic and Pain, Neuropathic, run by Baskent University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathy, Diabetic, Pain, Neuropathic, Gait Disorder, Sensorimotor
- What is being tested?
- Gait analysis and Balance Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 10 Dec 2021to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Hacettepe University
Ankara, 06230
Baskent University
Ankara, 06790
Fizyocare Rehabilitation Center
Ankara
About this study
Official title: Assessment of Balance and Gait in Patients With Diabetic Peripheral Neuropathy
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.
Read more
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.
Read the 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.
In the literature, although studies are examining kinetic analyzes of gait in patients with diabetic neuropathy, few studies were evaluating kinematic analyzes and stability limits. In addition, the balance and gait parameters of patients with neuropathy were compared with healthy individuals in studies, but no study compared with diabetic patients without neuropathy. Therefore, the aim of the study is to evaluate the effects of neuropathic pain due to type 2 diabetes on balance and gait.
METHODS 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 Ankara-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.
The groups will:
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) A written informed consent form is being obtained from all individuals.
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
Assessments
Information Form:
The researchers record individual and clinical characteristics of individuals such as age, gender, height, body weight, marital status, education level, duration of complaints, and dominant side.
Douleur Neuropathique en 4 questions (DN4):
DN4 is a scale consisting of 10 questions evaluating neuropathic pain. Seven items are related to pain symptoms and three items include a clinical examination. The scale asks whether patients have burning, painful cold, electric shock, tingling, prickling, numbness, and itching. In addition, sensory changes in the patient are examined with cotton, pins, and brushing. While 1 point is given for each item in scoring, a score of 4 or more indicates the presence of neuropathic pain. Taking 4 points or more from the DN4 is one of the criteria for identifying neuropathic pain in the study.
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS):
The LANSS is a validated questionnaire that consists of 7 items, can distinguish neuropathic pain from nociceptive pain, and is easy to score in clinical settings. The first part of the scale consists of 5 items questioning the pain symptoms and answered as yes or no. The patient is asked to think about the pain he or she has felt during the past week. In the second part, the presence of allodynia and the sharp-blunt threshold value is evaluated by sensory examination. The questionnaire is calculated between 0-24 points. Twelve points and above indicates neuropathic pain. Taking below 12 points from the LANSS scale is one of the criteria for identifying neuropathic pain in the study.
Visual Analog Scale (VAS):
VAS is a scale that evaluates pain on a horizontal 100 mm line. On the line, the left side indicates 'no pain' and the right side indicates 'the most severe pain imaginable. Healthy individuals are asked to mark a point on the line according to the severity of the pain they feel.
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 dynamic foot pressure distribution is also analyzed with the pedobarography integrated into this system. The system consists of a treadmill and a computer. For gait assessment, patients walk at their preferred comfortable walking speed. In the evaluation, joint angles, walking speed, step lengths,right-left and anterior-posterior weight transfer, left-right foot rotation, lateral mobility, the center of gravity movement, and swing area are recorded. Evaluation time is approximately 5 minutes.
Balance:
Static and dynamic balance and stability limit values are evaluated with the E-LINK FP3 Force Plate (Biometrics Ltd, United Kingdom) system. 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. 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. The measurement takes an average of 10 minutes.
Statistical Analysis For the sample size calculation G*Power Ver. 3.0.10 (Franz Faul, Universität Kiel, Germany) was used. Step length is the primer outcome of the study from the reference article. The analysis was carried out with an effective width of f=0.59, a power of 90%, and a margin of error of 0.05. It was found that 14 individuals in all three groups and a total of 42 individuals should be included in the study.
The data of the study will be analyzed by using the Statistical Program for Social Sciences (SPSS) version 23.0 (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp.). Descriptive data will be given as mean and standard deviation if numerical variables provide the parametric assumption, if not, median and minimum-maximum values will be given. Qualitative variables will be given with frequency and percentage values. Kruskal Wallis Test will be used for the comparison of independent samples. All the statistical analyses will be set a priori at an alpha level of p<0.05
- Being tested
- Gait analysis, Balance Assessment
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisDiagnostic 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.
Balance AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) Receives: Diagnostic Test: Gait analysis; Diagnostic Test: Balance Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Dec 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Neuropathy, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Ozlem Yuruk, Baskent University
- Investigators
- Ozlem Yuruk, Assoc.Prof, Study director, Baskent UniversitySuleyman Korkusuz, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127538
- Sponsor's protocol ID
- KA21/317
- Status last verified
- Feb 2022
- First submitted
- 9 Nov 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anjos DM, Gomes LP, Sampaio LM, Correa JC, Oliveira CS. Assessment of plantar pressure and balance in patients with diabetes. Arch Med Sci. 2010 Mar 1;6(1):43-8. doi: 10.5114/aoms.2010.13506. Epub 2010 Mar 9.
PubMed 22371719Awotidebe TO, Ativie RN, Oke KI, Akindele MO, Adedoyin RA, Olaogun MO, Olubayode TE, Kolawole BA. Relationships among exercise capacity, dynamic balance and gait characteristics of Nigerian patients with type-2 diabetes: an indication for fall prevention. J Exerc Rehabil. 2016 Dec 31;12(6):581-588. doi: 10.12965/jer.1632706.353. eCollection 2016 Dec.
PubMed 28119881Huang 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.
PubMed 30442545Simmons RW, Richardson C, Pozos R. Postural stability of diabetic patients with and without cutaneous sensory deficit in the foot. Diabetes Res Clin Pract. 1997 Jun;36(3):153-60. doi: 10.1016/s0168-8227(97)00044-2.
PubMed 9237781Tapp 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.
PubMed 12581261Lafond 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.
PubMed 14693985Allet L, Armand S, Aminian K, Pataky Z, Golay A, de Bie RA, de Bruin ED. An exercise intervention to improve diabetic patients' gait in a real-life environment. Gait Posture. 2010 Jun;32(2):185-90. doi: 10.1016/j.gaitpost.2010.04.013. Epub 2010 May 14.
PubMed 20471273Dyck PJ, Overland CJ, Low PA, Litchy WJ, Davies JL, Dyck PJ, O'Brien PC; Cl vs. NPhys Trial Investigators; Albers JW, Andersen H, Bolton CF, England JD, Klein CJ, Llewelyn JG, Mauermann ML, Russell JW, Singer W, Smith AG, Tesfaye S, Vella A. Signs and symptoms versus nerve conduction studies to diagnose diabetic sensorimotor polyneuropathy: Cl vs. NPhys trial. Muscle Nerve. 2010 Aug;42(2):157-64. doi: 10.1002/mus.21661.
PubMed 20658599Barrett AM, Lucero MA, Le T, Robinson RL, Dworkin RH, Chappell AS. Epidemiology, public health burden, and treatment of diabetic peripheral neuropathic pain: a review. Pain Med. 2007 Sep;8 Suppl 2:S50-62. doi: 10.1111/j.1526-4637.2006.00179.x.
PubMed 17714116Higgins 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.
PubMed 33070667Izgu 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.
PubMed 32536026Gok 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.
PubMed 29338623Allet 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.
PubMed 19900232Almurdhi 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.
PubMed 28103405Mustapa 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.
PubMed 27525281
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Balance and Gait in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05127538
- Acronym / sponsor ID
- KA21/317
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In the literature, although studies are examining kinetic analyzes of gait in patients with diabetic neuropathy, few studies were evaluating kinematic analyzes and stability limits. In addition, the balance and gait parameters of patients with neuropathy were compared with healthy individuals in studies, but no study compared with diabetic patients without neuropathy. Therefore, the aim of the study is to evaluate the effects of neuropathic pain due to type 2 diabetes on balance and gait.
METHODS 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 Ankara-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.
The groups will:
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) A written informed consent form is being obtained from all individuals.
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
Assessments
Information Form:
The researchers record individual and clinical characteristics of individuals such as age, gender, height, body weight, marital status, education level, duration of complaints, and dominant side.
Douleur Neuropathique en 4 questions (DN4):
DN4 is a scale consisting of 10 questions evaluating neuropathic pain. Seven items are related to pain symptoms and three items include a clinical examination. The scale asks whether patients have burning, painful cold, electric shock, tingling, prickling, numbness, and itching. In addition, sensory changes in the patient are examined with cotton, pins, and brushing. While 1 point is given for each item in scoring, a score of 4 or more indicates the presence of neuropathic pain. Taking 4 points or more from the DN4 is one of the criteria for identifying neuropathic pain in the study.
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS):
The LANSS is a validated questionnaire that consists of 7 items, can distinguish neuropathic pain from nociceptive pain, and is easy to score in clinical settings. The first part of the scale consists of 5 items questioning the pain symptoms and answered as yes or no. The patient is asked to think about the pain he or she has felt during the past week. In the second part, the presence of allodynia and the sharp-blunt threshold value is evaluated by sensory examination. The questionnaire is calculated between 0-24 points. Twelve points and above indicates neuropathic pain. Taking below 12 points from the LANSS scale is one of the criteria for identifying neuropathic pain in the study.
Visual Analog Scale (VAS):
VAS is a scale that evaluates pain on a horizontal 100 mm line. On the line, the left side indicates 'no pain' and the right side indicates 'the most severe pain imaginable. Healthy individuals are asked to mark a point on the line according to the severity of the pain they feel.
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 dynamic foot pressure distribution is also analyzed with the pedobarography integrated into this system. The system consists of a treadmill and a computer. For gait assessment, patients walk at their preferred comfortable walking speed. In the evaluation, joint angles, walking speed, step lengths,right-left and anterior-posterior weight transfer, left-right foot rotation, lateral mobility, the center of gravity movement, and swing area are recorded. Evaluation time is approximately 5 minutes.
Balance:
Static and dynamic balance and stability limit values are evaluated with the E-LINK FP3 Force Plate (Biometrics Ltd, United Kingdom) system. 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. 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. The measurement takes an average of 10 minutes.
Statistical Analysis For the sample size calculation G*Power Ver. 3.0.10 (Franz Faul, Universität Kiel, Germany) was used. Step length is the primer outcome of the study from the reference article. The analysis was carried out with an effective width of f=0.59, a power of 90%, and a margin of error of 0.05. It was found that 14 individuals in all three groups and a total of 42 individuals should be included in the study.
The data of the study will be analyzed by using the Statistical Program for Social Sciences (SPSS) version 23.0 (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp.). Descriptive data will be given as mean and standard deviation if numerical variables provide the parametric assumption, if not, median and minimum-maximum values will be given. Qualitative variables will be given with frequency and percentage values. Kruskal Wallis Test will be used for the comparison of independent samples. All the statistical analyses will be set a priori at an alpha level of p<0.05
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with neuropathic pain due to type 2 diabetes | Active comparator | Diagnostic Test: Gait analysis, Diagnostic Test: Balance Assessment* 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 |
| Individuals with type 2 diabetes but no neuropathic pain | Active comparator | Diagnostic Test: Gait analysis, Diagnostic Test: Balance Assessment* 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 |
| Healthy control group | Active comparator | Diagnostic Test: Gait analysis, Diagnostic Test: Balance Assessment* Individuals between the ages of 40-65 * Individuals who have no pain (Taking 1 point or less according to the Visual Pain Scale) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysisGait 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 | Healthy control group, Individuals diagnosed with neuropathic pain due to type 2 diabetes, Individuals with type 2 diabetes but no neuropathic pain |
| Balance AssessmentStatic 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. | Diagnostic test | Healthy control group, Individuals diagnosed with neuropathic pain due to type 2 diabetes, Individuals with type 2 diabetes but no neuropathic pain |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 22371719Anjos DM, Gomes LP, Sampaio LM, Correa JC, Oliveira CS. Assessment of plantar pressure and balance in patients with diabetes. Arch Med Sci. 2010 Mar 1;6(1):43-8. doi: 10.5114/aoms.2010.13506. Epub 2010 Mar 9.
- Background: PubMed 28119881Awotidebe TO, Ativie RN, Oke KI, Akindele MO, Adedoyin RA, Olaogun MO, Olubayode TE, Kolawole BA. Relationships among exercise capacity, dynamic balance and gait characteristics of Nigerian patients with type-2 diabetes: an indication for fall prevention. J Exerc Rehabil. 2016 Dec 31;12(6):581-588. doi: 10.12965/jer.1632706.353. eCollection 2016 Dec.
- Background: PubMed 30442545Huang 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.
- Background: PubMed 9237781Simmons RW, Richardson C, Pozos R. Postural stability of diabetic patients with and without cutaneous sensory deficit in the foot. Diabetes Res Clin Pract. 1997 Jun;36(3):153-60. doi: 10.1016/s0168-8227(97)00044-2.
- Background: PubMed 12581261Tapp 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.
- Background: PubMed 14693985Lafond 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.
- Background: PubMed 20471273Allet L, Armand S, Aminian K, Pataky Z, Golay A, de Bie RA, de Bruin ED. An exercise intervention to improve diabetic patients' gait in a real-life environment. Gait Posture. 2010 Jun;32(2):185-90. doi: 10.1016/j.gaitpost.2010.04.013. Epub 2010 May 14.
- Background: PubMed 20658599Dyck PJ, Overland CJ, Low PA, Litchy WJ, Davies JL, Dyck PJ, O'Brien PC; Cl vs. NPhys Trial Investigators; Albers JW, Andersen H, Bolton CF, England JD, Klein CJ, Llewelyn JG, Mauermann ML, Russell JW, Singer W, Smith AG, Tesfaye S, Vella A. Signs and symptoms versus nerve conduction studies to diagnose diabetic sensorimotor polyneuropathy: Cl vs. NPhys trial. Muscle Nerve. 2010 Aug;42(2):157-64. doi: 10.1002/mus.21661.
- Background: PubMed 17714116Barrett AM, Lucero MA, Le T, Robinson RL, Dworkin RH, Chappell AS. Epidemiology, public health burden, and treatment of diabetic peripheral neuropathic pain: a review. Pain Med. 2007 Sep;8 Suppl 2:S50-62. doi: 10.1111/j.1526-4637.2006.00179.x.
- Background: PubMed 33070667Higgins 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.
- Background: PubMed 32536026Izgu 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.
- Background: PubMed 29338623Gok 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem Yuruk, Assoc.Prof study director
Baskent University
Suleyman Korkusuz, MSc principal investigator
Hacettepe University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis and Balance Assessment in people with Neuropathy, Diabetic and Pain, Neuropathic, run by Baskent University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length (time frame: 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127538, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.