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NCT07274735
DPN often leads to balance issues, sensory deficits, and chronic pain, which can severely impact daily functioning and independence. INF therapy aims to improve nerve blood flow and alleviate neuropathic symptoms through manual techniques, while the Otago Exercise Program focuses on enhancing strength and balance to reduce fall risk. By comparing these two interventions, this study seeks to identify effective strategies that can improve balance, reduce pain, and enhance the quality of life for individuals suffering from DPN
NCT07270328
This pilot feasibility and exploratory study, conducted to prepare for a definitive Randomized Controlled Trial (RCT), compares a structured foot-ankle exercise program with a walking exercise program in adults with Diabetes Mellitus (DM). The primary aim is to assess feasibility, including recruitment rate, retention, adherence, data completeness, acceptability, and adverse events, to inform procedures for the definitive RCT. The secondary (exploratory) aim is to obtain preliminary estimates of effects on Diabetic Peripheral Neuropathy (DPN), stress, and obstacles to Diabetes-Related Quality of Life (DR-QoL), Fasting Blood Glucose (FBG), Body Mass Index (BMI), blood pressure, and Ankle-Brachial Index (ABI). Participants were allocated to three parallel arms for 12 weeks: 1. Foot-ankle exercise (education plus printed materials; independent practice 2-3 sessions/day), 2. Walking exercise (education plus printed materials; ≥150 minutes/week, ≥10 minutes/session, avoiding two consecutive non-exercise days), or 3. Active control (education and printed materials). Outcomes were assessed at baseline (day 0), week 6, and week 12. Analyses focus on feasibility metrics against pre-specified progression criteria and on hypothesis-generating estimates of within- and between-group change in neuropathy, stress, and obstacles to DR-QoL; the study is not powered for definitive efficacy. Retrospective registration note: This study was registered retrospectively after participant enrolment had begun and data collection had been completed. This retrospective status is disclosed for transparency; exploratory outcome analyses are interpreted accordingly, and adverse events related to exercise were monitored and reported.
NCT06483620
PURPOSE: This study will translate, culturally adapt, validate, and test the reliability of the Neuro Qol Arabic version to be used with diabetic patients in Arabic countries. Background: The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument is a multidimensional scale was developed to assess the QoL of diabetic patients with peripheral neuropathy. Producing Arabic versions of the Translating Scale can help researchers investigate offloading treatment among the Arabic population with DFUs. Hypotheses: The study design was a cross-cultural validation of NeuroQol, the Arabic version, for patients with DFUs. Research Question: Will there be cultural adaptation, validation, and reliability between the (Neuro Qol) Arabic version and the original language?
NCT07128836
Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, profoundly affecting quality of life with sensory disturbances and associated complications. Proprioceptive training shows promise in improving proprioception and functional outcomes in patients with peripheral neuropathy. Also the literature has shown that Insole vibrator demonstrates potential in mitigating symptoms and improving sensory function and balance in patients with peripheral neuropathy. This study aims to determine the effects of insole vibration with proprioceptive training on balance and functional ability in patient with diabetic peripheral neuropathy. In this randomized controlled trial design, 60 participants will be recruited. The sample size was calculated through G-power total of 60 participants. Who meet the inclusion criteria will be recruited through non-probability convenience sampling technique, which will further be randomized through online randomizer tool into control and experimental group with thirty participants in each group. Experimental group will receive proprioceptive training alongside vibrating insole and control group will receive proprioceptive training with non vibrating insoles. Data will be collected by using various assessment tools, including Numeric Pain Rating Scale for pain,Time Up And Go Test for functional mobility, Neuropathic Disability Score for level of disability ,Functional Reach Test for standing stability, Mini BESTS for balance, functional mobility and gait, Single Leg Stance Test for static posture and balance control and the Montreal Cognitive Assessment for cognitive impairment. Pre-intervention assessments will be conducted for both groups. The effects of the interventions will be measured at pre-treatment, 6th week, 12th week and at 16th week. Data analysis will be performed by using SPSS 26. Mixed ANOVA and repeated-measures ANOVA will use for within-group analysis whereas between-group analysis will perform by using one-way ANOVA. Key words: Diabetic polyneuropathy, Vibrating insole, proprioceptive training, balance
NCT07100301
Diabetic Peripheral Neuropathy (DPN) affects approximately half of people with Diabetes Mellitus (DM). Its repercussions on the musculoskeletal system and biomechanics mainly impact balance and locomotor function. Therefore, this study is justified by the need to design effective treatment alternatives for the motor alterations observed in people with DPN. The objective of this study will be to evaluate the effectiveness of an exercise program for the trunk, hip, knee and ankle, consisting of muscle strengthening and sensorimotor training, in the treatment of motor deficits caused by DPN. This will be a single-blind randomized clinical trial in which 64 individuals with type 2 DM and DPN will be randomly distributed between the experimental and control groups. The primary outcome will be the kinematic analysis of gait. The secondary outcomes will be: muscle strength assessed by dynamometry and the 30-second sit-to-stand test (30STS), and functional mobility through the Timed Up and Go (TUG) test. Assessments will be performed before the start of the intervention, at the end of the intervention, and at the one-month follow-up. The experimental group will perform a 12-week proximal/distal exercise program (trunk, hip, knee, and ankle). The control group will perform a distal exercise program (ankle and foot). The proposed exercise program is expected to show consistently positive results compared to the control group.
NCT07028528
The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN. Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.
NCT06287736
This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.
NCT04222660
Peripheral neuropathy affects about 50% of the diabetic population and there is no treatment other than good blood glucose control, which is ineffective in subjects with type 2 diabetes. Part of the problem for the lack of an effective treatment is the inability to detect peripheral neuropathy in its early stage. The hypotheses to be addressed in the first phase of this study is that changes in cornea sensitivity (blinking and squinting) following addition of a hyperosmotic solution will provide a novel screening tool for early diagnosis of peripheral neuropathy. For the second phase of the study the investigators will examine the effect of fish oil treatment of diabetic subjects with neuropathy on corneal nerve density and sensitivity. Corneal nerves are the most highly innervated part of the human body with great sensitivity. The first phase will use this property and determine whether sensitivity is lost in diabetic patients with neuropathy. Preclinical studies have supported this hypothesis and now this will be tested in human subjects. Preclinical studies have also shown that treating diabetic rodents with fish oil improves nerve regeneration and outcome measures of peripheral in diabetic rodents. In the second phase the investigators will perform preliminary studies in human subjects with diabetic neuropathy and determine whether treating them with fish oil increases corneal nerve density and sensitivity.
NCT06740227
The objective of this study is to determine the effects of virtual reality based balance training compared to conventional balance training to reduce risk of fall in patients with diabetic peripheral neuropathy in terms of fall and gait parameters. The study is a non-blinded randomized control trial, consisting of 2 groups. The Study will be conducted at Fauji Foundation Hospital and Foundation University Islamabad. A calculated sample of 30 subjects will be selected via non-probability convenience sampling technique followed by randomization into two groups using envelope method. After CBRC registration, ethical approval is obtained from ERC FUMC. Individuals fulfilling the inclusion criteria is selected, followed by written informed consent after explaining the study purpose. Participants is then be randomly allocated to one of the 2 groups. At the baseline, Fall Efficacy Scale (FES), Activity-specific Balance Confidence (ABC), Time Up and Go Test and Dynamic Gait Index (DGI) are assessed. Control group is provided with conventional balance training. Treatment group is provided with the Virtual Reality (Wii Fit) Based Balance Training. Exercise training is performed thrice a week on alternate days for a total duration of 18 sessions over 06 week. All outcome measurements would be performed before and then after the 6-weeks intervention period. Data will be entered and analyzed on SPSS v. 22.
NCT06663670
The aim of this study is to determine the comparative effects of intraneural facilitation therapy and nerve flossing technique on pain, balance, gait, and quality of life in Diabetic peripheral neuropathy.
NCT06688708
1. This study had the objectives to investigate the long-term and remaining effects of using a novel vibrating foot orthosis for tactile stimulation in diabetic peripheral neuropathy (DPN). 2. The hypothesis of this study was using the VFO in conjunction with a random square wave pulse stimulus and pseudorandom white noise via a stochastic resonance could effectively improve tactile sensitivity and reduce vibration perception threshold (VPT). 3. Participants were recruited from the HRH Princess Maha Chakri Sirindhorn Medical Centre (Srinakharinwirot University), Ongkharak, Nakhon Nayok, Thailand. 4. 64 type 2 diabetes mellitus people with mild-to-moderate peripheral neuropathy were recruited. 5. Approach to participant: use purposive sampling by direct contact the patients who match the inclusion criteria. 6. Informed Consent Process: the information sheet was provided to participants, and the researcher explained the objectives of the study, the duration of the research, the research method, the dangers or potential effects of the research, including the benefits that might arise from the research and other methods of treatment in details. The participants had enough time and opportunity to ask questions until they had a good understanding. The researchers willingly answered questions without hiding them, until they satisfied. Then, the participants had to willingly sign a consent form prior to participate in the research project with voluntary. 7. The study protocol was approved by the Human Research Ethics Committee of Srinakharinwirot University (SWUEC-661032). 8. A randomized sham-controlled trial was conducted in this study. The experiments in this study were performed in a parallel design with random allocation and a double-blind strategy (blinded participants and investigators). 9. Baseline characteristics were assessed including: muscle strength by manual muscle testing, grading by the Medical Research Council; sensation by the Semmes-Weinstein monofilament test (5.07 gauge, 10 g pressure size) with 10-site examination; peripheral neuropathy by the Michigan neuropathy screening instrument; vibratory perception by a tuning fork (a graduated Rydel-Seiffer version); body mass index; circulatory system examination by palpating dorsalis pedis and posterior tibial pulse; pathology of diabetic foot; VPT by the Vibratory Sensory Analyzer: VSA-3000 (Medoc Ltd., USA). 10. VPT values were determined as the outcome parameter. 11. Statistical methods: * Quantitative data will be presented with median (mean) and standard deviation (SD). * Qualitative data will be presented with numbers and percentages. * An independent t-test will be used to compare the independent outcomes. * A paired t-test will be used to compare the dependent outcomes. * A repeated-measures ANCOVA will be used for between group comparisons. * A repeated-measures ANOVA will be used for within-group comparison. * MANCOVA will be used for analyzing the covariates' effect on the relationship between the independent grouping variables and the continuous dependent variables. * Cohen's d will be used to determine the effect sizes. 12. Ethical Consideration (1) All participants were provided with detailed project information prior to participation in the research project. (2) While conducting experiments, evaluating, collecting research results, a prosthetist and orthotist (PO) and a physician will be with the participants at all times to prevent possible accidents/adverse events. (3) If there is any harm from the research, free medical treatment will be provided. (4) During research participation, all participants have the rights to withdraw at any time without the need to give reasons. (5) All information obtained from the research project will be kept as a secret, and will be disclosed to the public for academic benefits without the participants' name. 13\. Expectable benefits and applications 1. Using the novel VFO may lead to efficient treatment for neurorehabilitation in DPN. 2. The investigators hope that this low-cost VFO can offer advantages such as affordability, widespread use, and home-based applications. 3. The benefits of using the novel VFO that can improve tactile sensation on the plantar surface of the foot in diabetic peripheral neuropathy. 4. Employing the novel VFO can reduce VPT. 5. Using the novel VFO can help prevent diabetic foot ulceration (DFU), lessen a risk of DFU recurrence, and avoid lower limb amputation. 6. Applying the novel VFO may help restore and prolong tactile sensation. 7. Using the novel VFO may aid in slowing DPN deterioration and decreasing peripheral nervous system impairment. 8. Utilizing the VFO may help improve quality of life for DPN people. 14\. Compensations for participants * Payment was provided for those participants who attend throughout the study. * All participants received a custom-made foot orthosis after completing the study.
NCT06303453
The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.
NCT06519942
The goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus (T2DM) with a common complication of T2DM: diabetic peripheral neuropathy (DNP), specifically diabetic sensorimotor polyneuropathy. Researchers will also look into factors related to DNP: inflammation, the use of energy in the cell, nerve function and the tiny blood vessels in the muscle. The main question it aims to answer is: Are there differences in muscle fiber type composition between persons with T2DM with and without DNP, in comparison to sex and age-matched healthy peers? Participants will partake in the following tests: * electromyoneurography (EMNG): evaluation of nerve function, damage and repair; for diagnosis of DNP or other diseases of the nerves * blood analysis: researchers will measure insulin, blood sugar, lipid profile, inflammation * muscle biopsy in the calf (m. gastrocnemius): a doctor will take a small sample of muscle to evaluate the muscle shape and structure * mechanography: patients will perform functional tests (e.g. standing up from a chair), researchers will evaluate maximal power and maximal force of the muscles by jumping tests * questionnaires: on food intake, physical activity, smoking history, alcohol use, medical history * measurement of height, weight, and the comparison of the hip and waist circumference * peripheral Quantitative Computed Tomography (pQCT): scan of the calf for muscle density and bone density * electrocardiography (ECG): evaluation of electrical signals of the heart Researchers will compare (1) patients with T2DM with DNP, (2) patients with T2DM without DNP, and (3) healthy persons to see if there are differences in muscle fiber type composition
NCT06130917
Upto the best knowledge of researcher, multisystem exercise program has been utilized in various populations, encompassing both healthy individuals and patients with diverse medical conditions. However, its specific impact on the diabetic peripheral neuropathy population, particularly in terms of improving balance, postural stability and mobility remains inadequately explored.
NCT05993871
The aim of work is to study the clinical, electrodiagnostic and neurosonographic characteristics of diabetic patients with small fiber neuropathy in the Egyptian population, and to evaluate both the diagnostic and the prognostic impact of the studied factors on the neuropathy severity and quality of life.
NCT05041816
The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.
NCT04688671
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.
NCT05848180
Diabetes being a very prevalent condition results in various complications including neuropathy, which can impair various functional outcomes in patients including balance. Ankle proprioceptive training (APT) is an intervention that is used to tackle this problem. The study will compare APT with standard balance training in subjects with diabetic neuropathy.
NCT06074913
Part Ⅰ:Infrared thermograms of four parts of the soles of the feet, dorsum of the feet, palms of the hands, and dorsum of the hands of healthy volunteers, diabetic patients, and patients with diabetic peripheral neuropathy were collected by using infrared thermography, and the patterns of change in the average temperatures of the parts of the participants in the three groups were analysed and compared by using the accompanying software. Part Ⅱ: Diabetic Peripheral Neuropathy (DPN) mainly presents with symmetrical pain,numbness, and ankylosing sensation, but reversal after diagnosis is particularly difficult. Electroacupuncture can significantly improve the function of peripheral nerves, regulate local blood flow, and reduce the inflammatory response to promote nerve regeneration, but no study has shown that electroacupuncture can effectively prevent the occurrence of DPN. Therefore, it is of great research significance to determine whether electroacupuncture has the possibility in preventing the occurrence of DPN.
NCT05507697
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications in type 2 diabetes, conventional drug therapy can only target a single pathogenesis but not treat Diabetic Peripheral Neuropathy (DPN) fundamentally. As a novel technique, stem cell transplantation provides a new option for patients with DPN. In 2012, Wuhan Central Hospital, took the lead in carrying out clinical research on the treatment of DPN with autologous bone marrow stem cells in China, and patients were significantly relieved. Based on this research, our clinical trial is to evaluate the safety and efficacy of HUC-MSCs in the treatment of refractory diabetic peripheral neuropathy (DPN) by formulating standard operating procedures (SOP) and quality standards (QS) to explore the possible mechanism of HUC-MSCs in the treatment of DPN.