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Completed

NCT Number: NCT07712289

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

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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Roods Facilitatory Technique

Other

Quick stretch and Heavy compression technique targeted areas of lower extremities

Textured Insoles

Device

Participants wore allocated insoles, in their own shoes, as much as possible.

Primary outcomes

  1. BBS

    Time frame: Four weeks

    Berg Balance Scale

Secondary outcomes

  1. MNSI

    Time frame: Four weeks

    Michigan Neuropathy Screening Instrument

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Official study title

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

Acronym: DNP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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