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NOT YET RECRUITING
NCT07619794
NA

tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy

Sponsor: Riphah International University

View on ClinicalTrials.gov

Summary

tSCS and AR-based training have individually shown benefits in neuromotor rehabilitation; no study to date has evaluated their combined effects on pain, balance, lower-limb strength, retention, and vibration sense in diabetic neuropathy. The rationale for combining them lies in their complementary mechanisms: tSCS at 30 Hz activates large-diameter Aβ afferents, inhibiting nociceptive input, enhancing spinal excitability, and facilitating motor activation.

Official title: Combined Effects of Transcutaneous Spinal Cord Stimulation (tSCS) and Augmented Reality (AR) Training on Pain and Balance in Diabetic Neuropathy Patients.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-06-15

Completion Date

2027-01-31

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

OTHER

transcutaneous spinal cord stimulation

Transcutaneous spinal cord stimulation will be administered non-invasively using surface electrodes placed over the D12-L1 spinal segment. This segmental level has been shown to effectively engage lower-limb motor and sensory networks across multiple spinal segments. Stimulation will be delivered using the Soterix 1×1 Transcutaneous Electrical Stimulation (TES) unit. Stimulation will be applied at a frequency range of 30 Hz. Pulse duration of 1 ms, and intensity will be set at 2 mA. A ramp-up and ramp-down time of 30 seconds will be used to enhance participant comfort during the start and end of each stimulation session, following standardized electrode placement and safety protocols.

OTHER

Augmented Reality

AR-based rehabilitation will consist of interactive balance and coordination tasks conducted in a virtual environment, with real-time visual feedback provided to guide movement accuracy and postural control. The core training block will include five structured modules: interactive kicking exercises to promote ankle and knee coordination; color-target foot-reaching tasks to enhance proprioception and reaction time; virtual obstacle navigation to improve gait and stepping control; static and dynamic balance challenges, such as maintaining posture on virtual planks; and lower-limb strengthening activities, including squats and stepping-based games. Each module will be performed for 5-8 minutes, with brief rest periods between tasks.

Locations (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan