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NCT Number: NCT07619755

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

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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Pakistan has seen a rise in diabetes prevalence, 26.7% among adults, with 43.16% developing neuropathy. This high prevalence is associated with significant complications. Approximately 15% of these cases can progress to limb amputation, which severely impacts QoL, increases dependence on caregivers, and imposes long-term psychosocial and economic stress on patients and their families.

Transcutaneous spinal cord stimulation (tSCS) is a noninvasive neuromodulation technique that involves the application of electrical stimuli over the thoracic or lumbar spinal cord regions. Studies suggest that tSCS may influence afferent sensory pathways, potentially improving vibration perception and proprioceptive feedback, particularly at 30Hz, resulting in enhanced QoL.

Augmented reality (AR)-based rehabilitation has also emerged as a non-invasive tool to enhance balance, postural control, and motor learning in patients with diabetic neuropathy. Recent studies support the use of immersive AR environments in improving lower limb flexibility, gait, and functional performance in neuropathy patients, thus increasing their QoL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than or equals to 4 scores on Douleur Neuropathique 4 Questionnaire (DN4)
  • More than or equals to 6 Hz at Neurothesiometer

Exclusion criteria

  • Cognitively compromised (MOCA score ≤ 26/30)
  • Metallic implants at skull
  • Shunting
  • Skin allergy

Treatment and study plan

Transcutaneous spinal cord stimulation Group

Other

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

Augmented Reality

Other

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.

Primary outcomes

  1. International Physical Activity Questionnaire

    Time frame: Up to week 5

    The IPAQ assesses physical activity across four domains: work, transport, domestic, and recreation time. It includes 27 items and collects data on frequency and duration of physical activity at three intensity levels; high, moderate, and low. The IPAQ has Test-retest reliability ICC = 0.80. the score is calculated by converting activity into MET-minutes/week. Low activity: < 600 MET-min/week, Moderate activity: 600-3000 MET-min/week and High activity: > 3000 MET-min/week.

    Outcome will be measured at Baseline then Week 1 and then week 5

  2. Diabetes Quality of Life Questionnaire

    Time frame: Up to week 5

    The Diabetes Quality of Life (D-QoL) questionnaire is a disease-specific instrument originally developed for the diabetes control and complications trial (DCCT) to assess the quality of life in individuals with diabetes mellitus. It has 46 items divided into three main domains: satisfaction, impact, and worry. Each item is rated on a likert scale, with higher scores indicating greater impact, or concern. The tool assesses the individual's perception of how diabetes affects various aspects of life, including daily activities, social functioning, and emotional well-being. The D-QoL has demonstrated strong reliability and validity, with internal consistency ranging from 0.73 to 0.94 for its subscales. Outcome will be measured at Baseline then Week 1 and then week 5

Secondary outcomes

  1. Neurothesiometer

    Time frame: Up to week 5

    The neurothesiometer is a non-invasive and reliable device for assessing vibration perception threshold (VPT). The neurothesiometer demonstrated excellent intra-class correlation coefficients (ICCs) exceeding 0.90, highlighting its consistency. The cut off value of ≥ 6hz indicates presence of neuropathy. This tool is beneficial in clinical settings due to its ease of use, objective quantification, and ability to detect subclinical neuropathy. The neurothesiometer offers superior standardization, making it a preferred method for evaluating protective sensation and vibration loss in diabetic populations. Outcome will be measured at Baseline then Week 1 and then week 5

  2. Sit and reach test

    Time frame: Up to week 5

    The sit-and-reach test is a widely used tool for assessing lower limb flexibility. The test demonstrates excellent reliability, with intra-class correlation coefficients (ICCs) ranging from 0.92 to 0.99, indicating strong consistency in repeated measures. Scoring is based on distances recorded in inches or centimeters, higher values indicate better flexibility. It is simple to administer, cost-effective, making it a reliable method for flexibility assessment in healthy adult populations. Outcome will be measured at Baseline then Week 1 and then week 5

Study contacts

Contact information is provided by the study sponsor or research team.

Fatima Zahra, DPT

CONTACT

[email protected]

0092 333 4133592

Mirza Obaid Baig, MSPT

CONTACT

[email protected]

00923332238706

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Transcutaneous Spinal Cord Stimulation (tSCS) and Augmented Reality (AR) Training on Quality of Life (QoL) and Physical Activity in Diabetic Neuropathy Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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