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

NCT07712289 | Completed

• 1 other identifier: TUF/IRB/96/2025
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Neuropathy; Diabetes

Keywords

Diabetes, diabetic neuropathy, insoles, textured insoles, roods technique, roods facilitatory technique

Outcome Measures

Primary Outcomes (1)

• BBS

  Berg Balance Scale

  Four weeks

Secondary Outcomes (1)

• MNSI

  Four weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A received contrast bath plus Rood's facilitatory techniques.

Other: Roods Facilitatory Technique

Group B

ACTIVE COMPARATOR

Group B received contrast bath plus textured insoles.

Device: Textured Insoles

Interventions

Textured Insoles DEVICE

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

Group B

Roods Facilitatory Technique OTHER

Quick stretch and Heavy compression technique targeted areas of lower extremities

Group A

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: March 4, 2025
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)