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Completed
NCT07712289
Comparative Analysis Between Textured Insoles and Roods Technique Affecting Balance in DNP.
Conditions: Diabetic Neuropathy, Diabetes
Sex: All
Ages: 45 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 44
Sponsor: University of Faisalabad
Location: The University of Faisalabad Faisalābad Punjab Province
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07712289). StuddyBuddy aggregates publicly available trial information.