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tSCS and AR Training on QoL and Physical Activity in Diabetic Neuropathy Patients

NCT07619755 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-02

No results posted yet for this study

Summary

Existing evidence of tSCS emphasizes pain relief and overlooks other functional parameters such as sensory enhancement, lower limb flexibility, and sustained improvements in physical activity and QoL.

Combined effects of tSCS and AR training on lower limb flexibility, vibration sense, QoL, and physical activity in patients with diabetic neuropathy. This dual approach has the potential to deliver a comprehensive strategy for managing DPN, which is low-cost, safe, and a more accessible solution for diabetic patients in Pakistan and around the world.

Conditions

  • Diabetic Neuropathy

Interventions

OTHER

Transcutaneous spinal cord stimulation Group

Transcutaneous spinal cord stimulation will be administered non-invasively using surface electrodes placed over the D12-L1 spinal segment. 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. The pulse duration is 1 ms, and the 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. The stimulation will be delivered in a comfortable sitting or lying position

OTHER

Augmented reality

AR-based rehabilitation will involve interactive balance and coordination tasks performed in a virtual environment all while receiving real-time visual feedback to guide movement accuracy and postural control. The main training block will comprise exercises focusing on hip flexion, hip abduction, knee flexion, and lateral weight shifting. Each module will be performed for 5-8 minutes, with short rest intervals between tasks.

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Mirza Obaid Baig, MSPT · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2026-12-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619755 on ClinicalTrials.gov