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" Effects of Task Oriented Training on Balance With or Without Textured Insoles in Patient With Peripheral Diabetic Neuropathy."

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Introduction Peripheral diabetic neuropathy (PDN) is a common complication of diabetes that can cause sensory impairment, poor balance, and increased risk of falls. Task-oriented balance training may improve functional balance, while textured insoles may provide additional sensory input from the feet. However, limited evidence is available regarding the combined effect of these interventions in patients with PDN. Objective The objective of this study is to determine the effect of task-oriented balance training with and without textured insoles on balance, functional mobility, and foot pain in patients with peripheral diabetic neuropathy. Methodology This randomized controlled trial will include 28 participants, randomly divided into Group A (n=14) and Group B (n=14). Group A will receive task-oriented balance training without textured insoles, while Group B will receive task-oriented balance training with textured insoles. The intervention will be provided for 4 weeks, 3 days per week. Pre- and post-intervention assessments will be performed using the Berg Balance Scale (BBS), Timed Up and Go (TUG), and Visual Analog Scale (VAS). The Michigan Neuropathy Screening Instrument (MNSI) will be used as a screening tool. Data will be analyzed using SPSS version 25. Descriptive statistics will include mean, standard deviation, frequencies, and percentages. Normality will be assessed using the Shapiro-Wilk test. Appropriate parametric or non-parametric tests will be used for within- and between-group comparisons.
Trial Details
NCT Number NCT07830173
Lead Sponsor Superior University
Conditions
(from sponsor)		 Balance Impairment in Peripheral Diabetic Neuropathy
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov