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

July 14, 2026 updated by: University of Faisalabad

Comparative Analysis Between Textured Insoles and Roods Facilitatory Technique Affecting Balance in Patients With Diabetic Neuropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • The university of Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A received contrast bath plus Rood's facilitatory techniques.
Other: Roods Facilitatory Technique
Quick stretch and Heavy compression technique targeted areas of lower extremities
Active Comparator: Group B
Group B received contrast bath plus textured insoles.
Device: Textured Insoles
Participants wore allocated insoles, in their own shoes, as much as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BBS
Time Frame: Four weeks
Berg Balance Scale
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MNSI
Time Frame: Four weeks
Michigan Neuropathy Screening Instrument
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Actual)

May 26, 2025

Study Completion (Actual)

May 26, 2025

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUF/IRB/96/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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