CompletedNot Applicable

Comparative Analysis Between Textured Insoles and Roods Technique Affecting Balance in DNP.

Pakistan44 participantsStarted 2025-03-04

Plain-language summary

The purpose of this randomized controlled trial is to compare the effectiveness of textured insoles versus Rood's facilitatory technique in improving balance in patients with diabetic neuropathy. The study aims to answer the following question: What is the comparative analysis between textured insoles and Rood's facilitatory techniques affecting balance in patient with diabetic neuropathy? Participants assigned into two groups. Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles. Treatment will be delivered over a four-week period, with three sessions per week on alternative days.

Who can participate

Age range

45 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Participants must have a clinical diagnosis of Type 2 diabetes. * Participants must show evidence of diabetic peripheral neuropathy (DPN) as diagnosed by clinical examination. * Participants with 25-40 Berg Balance Score. * Participants with 6-8(Patient version) and 2.5-4(Physical assessment) Michigan Neuropathy Score. * Participants aged 45 years to 60. * Participants taking medications. * Participants must be able to understand the study procedures and provide written informed consent. Exclusion Criteria * Participants who have significant cognitive impairments (e.g., dementia) that would prevent them from understanding and adhering to study instructions. * Participants with severe PAD or significant circulatory problems that would contraindicate the use of insoles or tactile stimulation therapy. * Participants with other neurological conditions that could confound the results. * Participants who have had recent surgery or trauma to the feet or lower extremities in the past 6 months. * Participants who are involved in another clinical trial. * Participants with active diabetic foot ulcers, severe deformities, infections, or other complications that would make it unsafe or inappropriate to use textured insoles.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BBS

Timeframe: Four weeks

Trial details

NCT IDNCT07712289

SponsorUniversity of Faisalabad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-26

View on ClinicalTrials.gov More Diabetic Neuropathy trials