Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neuropathy

NCT07380880 | Recruiting DMC

• 1 other identifier: UOL/IREB/25/15/03/29
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and is associated with sensory loss, impaired proprioception, balance deficits, and altered gait patterns, which significantly increase the risk of falls and functional dependence. Rehabilitation strategies targeting sensory and proprioceptive impairments are essential to improve postural control and mobility in this population. This randomized controlled trial aims to compare the effects of proprioceptive neuromuscular training and sensory re-education on balance and gait performance in patients with diabetic peripheral neuropathy. Participants diagnosed with DPN will be randomly allocated into two groups. Group A will receive sensory re-education, while Group B will undergo a structured proprioceptive training program. Both groups will also receive baseline conventional treatment. Balance and gait outcomes will be assessed using the Berg Balance Scale and the Dynamic Gait Index at baseline, mid-intervention, and post-intervention. The findings of this study may help determine the more effective rehabilitation approach for improving balance and gait in individuals with diabetic peripheral neuropathy, thereby reducing fall risk and enhancing functional independence.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Proprioceptive Neuromuscular Training; Sensory Re-education; Balance; Gait

Outcome Measures

Primary Outcomes (1)

• Balance Performance Assessed by the Berg Balance Scale

  The primary outcome is the change in balance performance in patients with diabetic peripheral neuropathy. Balance will be measured using the Berg Balance Scale (BBS), a validated tool consisting of 14 tasks evaluating both static and dynamic balance, scored from 0 (lowest function) to 4 (best performance), with a total maximum score of 56. Higher scores indicate better balance and mobility. Assessments will be conducted at baseline, at 3 weeks, and at 6 weeks post-intervention.

  Baseline, 3 weeks, and 6 weeks after the start of intervention

Study Arms (2)

group A Sensory Re-Education

EXPERIMENTAL

Participants in this group will receive a structured sensory re-education program for six weeks, with three sessions per week. Each session will include 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. Sensory re-education will involve stroking the affected skin using brushes and various textured materials, progressing from rough to soft textures over five minutes per session. Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention.

Behavioral: Sensory Re-Education Program

group B Proprioceptive Neuromuscular Training

ACTIVE COMPARATOR

Participants in this group will undergo a structured proprioceptive neuromuscular training program for six weeks, with three sessions per week. Each session will start with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. The main intervention will include balance exercises (bilateral stance, heel raises, single-leg stance with hip flexion, eyes open and closed), strengthening exercises targeting lower limb muscles (quadriceps, hamstrings, lateral thigh), plyometric exercises (single- and double-leg jumps with rotations), and agility drills (figure-eight and directional movements). Each session lasts approximately 30 minutes, and exercises will progress in intensity and complexity based on participant tolerance. Balance and gait outcomes will be measured using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention.

Behavioral: Proprioceptive Neuromuscular Training

Interventions

Sensory Re-Education Program BEHAVIORAL

Participants will undergo a six-week sensory re-education program, three sessions per week. Each session includes: Electrical Muscle Stimulation (EMS): 10 minutes applied to lower lumbar region and area of neuropathic discomfort (pulse width 100-200 µs, frequency 80-100 Hz, intensity as tolerated). Sensory Re-Education: Stroking the affected skin using brushes and textured materials (rough hessian, wool, satin, cotton, fur) for 5 minutes per session, progressing from coarse to soft textures. Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).

group A Sensory Re-Education

Proprioceptive Neuromuscular Training BEHAVIORAL

Participants will receive a structured proprioceptive neuromuscular training program for six weeks, three sessions per week. Each session begins with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort (pulse width 100-200 µs, frequency 80-100 Hz, intensity as tolerated). The main intervention consists of: Balance exercises: bilateral stance, heel raises, single-leg stance with opposite hip flexed, performed with eyes open and closed. Strengthening exercises: targeting lower limb muscles including quadriceps, hamstrings, and lateral thigh using squats and resistance exercises. Plyometric exercises: single- and double-leg jumps with 90° and 180° rotations to enhance coordination. Agility drills: figure-eight running and directional movements (forward, backward, lateral) along straight and spiral paths. Each session lasts approximately 30 minutes, with progressive intensity and complexity based on individual toleran

group B Proprioceptive Neuromuscular Training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both males and females Diagnosed with Diabetes Mellitus (Type 1 or Type 2) Aged between 40-75 years Presence of diabetic peripheral neuropathy (as confirmed by Michigan Neuropathy Assessment Tool or Toronto Clinical Rating Scale) HbA1c level \> 7% consistently over the last 6 months

You may not qualify if:

• Unable to ambulate independently or with assistance Any history of neurological disorders Any history of musculoskeletal disordersin the past 6 months Renal and liver failure History of Ischemic heart disease History of dizziness or balance-impairing conditions

Sponsors & Collaborators

• Montiha Azeem: lead

Study Sites (1)

Shadman Medical Center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

• Nimra Zaheer, MSPTN

  The University of Lahore, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimra Zaheer, MSPTN

CONTACT

03235018078; nimrazaheer62@gmail.com

Montiha Azeem, MSPTN

CONTACT

03479717317; muntahaazeem9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Model Description

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: February 10, 2026
• Primary Completion: March 30, 2026
• Study Completion: March 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

PA (1)