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ACTIVE NOT RECRUITING
NCT07830173
NA

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

Sponsor: Superior University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-08-24

Completion Date

2026-10-24

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

Task oriented balance training

Participants with peripheral diabetic neuropathy will receive a structured task-oriented balance training program designed to improve functional balance, postural control, and performance of balance-related daily activities. Each participant was given 3-5 sessions of task-oriented training per week for 6 weeks, each session 30-40 minutes in duration. Group A (Control Group - Task-Oriented Training Alone) The exercises in the Group A were structured task-oriented training program which is as follows: 1. Sit-to-Stand Training: 2. Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. 7. Walking Training. 8. Reaching Activities. Each participant was performing these exercises for three to five sessions per week for 6 weeks, with each session lasting between 30 and 40 minutes.

OTHER

task oriented training with textured insoles

Participants in the experimental group will use textured insoles with raised nodules designed to provide additional plantar sensory stimulation during standing and functional activities. The textured insoles will be used in combination with the task-oriented balance training program.1. Sit-to-Stand Training: 2\. Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. 7. Walking Training. 8. Reaching Activities.

Locations (1)

Superior University

Lahore, Punjab Province, Pakistan