NCT07380880

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Montiha Azeem · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Diabetic peripheral neuropathy is a progressive complication of diabetes characterized by sensory impairment, proprioceptive deficits, and neuromuscular dysfunction. These impairments adversely affect balance control and gait stability, increasing the likelihood of falls, injuries, and reduced quality of life. Despite the widespread use of rehabilitation interventions, there is limited comparative evidence regarding the effectiveness of sensory re-education versus proprioceptive neuromuscular training in improving functional outcomes among individuals with DPN. This randomized controlled trial will be conducted at the University Institute of Physical Therapy, Lahore, following approval from the Institute Research Ethics Board. Eligible participants with confirmed diabetic peripheral neuropathy will be recruited through referrals from endocrinologists and diabetologists. After obtaining informed consent, participants will be randomly assigned to either the sensory re-education group or the proprioceptive training group using a lottery method. The study will follow a single-blinded design, with outcome assessors blinded to group allocation. Both groups will undergo a six-week intervention program consisting of three supervised sessions per week. Balance and gait performance will be evaluated at baseline, at the third week, and at the completion of the intervention using standardized outcome measures. Data analysis will focus on comparing within-group and between-group changes over time. The results of this study are expected to provide evidence-based guidance for physical therapists in selecting effective rehabilitation strategies to improve balance and gait in patients with diabetic peripheral neuropathy, ultimately aiming to reduce fall risk and enhance functional mobility.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
BEHAVIORAL	Sensory Re-Education Program	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).
BEHAVIORAL	Proprioceptive Neuromuscular Training	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

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-03-30
• Completion: 2026-03-31
• First posted: 2026-02-02
• Last updated: 2026-02-03

Locations

1 site across 1 country: Pakistan