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IRCT20250212064710N1 IRCT 2025-03-12 Azin Shirin Comparison of sensory motor training effect with or without resistancetraining on performance, balance and pain in patients with diabeticperipheral neuropathy Comparison of sensory motor training effect with or without resistancetraining on performance, balance and pain in patients with diabeticperipheral neuropathy: A randomized controlled clinical trial 2025-02-08 anticipated 45 Complete https://irct.ir/trial/82025 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We performed randomization using the block randomization method to allocate participants into three groups. A predetermined block size was used to ensure an equal distribution of participants across groups. The randomization sequence was generated using a computer-based random number generator, and allocation was concealed to prevent selection bias. Participants were then assigned to their respective groups based on the generated sequence, ensuring that the allocation process was truly random and balanced, Blinding description: In this study, we applied single-blind blinding, meaning that participants were unaware of their group assignments. Additionally, the investigator responsible for administering interventions and the data analysts were blinded to the group allocations to minimize potential bias in outcome assessment and data interpretation. N/A Diabetes neuropathy. Intervention 1: Intervention group: sensory motor exercises. Intervention 2: Intervention group: Sensory-motor exercises + resistance training. Intervention 3: Control group: routin lifestyle. Yes - There is a plan to make this available What will be shared: The document contains research data related to title including anonymized individual participant data (IPD) and supporting materials. The data primarily focuses on Diabetics neurapathy, collected through Randomized controlled trials When: The data will be available starting from date mentioned prior and will remain accessible for six months after publication of results To whom: The data will be accessible to researchers affiliated with academic institutions and professionals in related industries, provided they submit a formal request. Conditions: Access will be granted based on ethical approval and alignment with the research objectives. Applicants must submit a research proposal detailing how the data will be used. Where to obtain: The data can be obtained from Shahid beheshti university by submitting a request through email mentioned in the file. How to obtain: Just email to: az.shirin@mail.sbu.ac.ir Comments:
public Dr Azam kouhkan
Aghdasieh, Golzar street, Neda alley, Royan diabetes clinic
Tehran Iran (Islamic Republic of) 1693913741 +98 912 279 6522 azamkouhkan@yahoo.com Royan diabetes clinics scientific Azin Shirin
Pasdaran, 10th Baharestan,No 2, floor 1
Tehran Iran (Islamic Republic of) 1234567890 +98 912 640 8725 az.shirin@mail.sbu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) diagnosed T2DM for at least 5years BMI was between 20 and 29.9 kg/m2 Subjects had scored more than 2/13 points in the Michigan neuropathyscreening instrument) questionnaire A score greater than 1/10 of the MNSI physical examination score, including vibrationperception impairment Score 4 to 6 in VAS Male and female subjects aged between 40 and 65 years 40 years 65 years Both DPN patients who do not eligible or give consent Absence in more than 3 meetings without any episode of plantar ulceration; no partial or total amputation; and ability to walk independently in thelaboratory. Patients were excluded from the study if they had any other neurological impairment; any major vascular complication; severe retinopathy; severe nephropathy; severe musculoskeletal impairment tolower limb; cardiovascular complication; and been receiving any supervised physical intervention E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified Treatment - Devices Treatment - Other Lifestyle Intervention group: sensory motor exercises Intervention group: Sensory-motor exercises + resistance training Control group: routin lifestyle Static balance. Timepoint: 8 weeks. Method of measurement: Single leg stance. Dynamic balance. Timepoint: 8 weeks. Method of measurement: FRT. Pain. Timepoint: 8 weeks. Method of measurement: VAS. Function. Timepoint: 8 weeks. Method of measurement: TUG. Azin Shirin Approved 2024-11-24 Royan institute Aghdasieh street Tehran Tehran Iran (Islamic Republic of)