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

NCT07619755 | Not Yet Recruiting

• 1 other identifier: REC02260 Fatima Zahra
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

neuropathy; transcutaneous spinal cord stimulation; quality of life; augmented reality

Outcome Measures

Primary Outcomes (2)

• International Physical Activity Questionnaire

  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

  Up to week 5

• Diabetes Quality of Life Questionnaire

  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

  Up to week 5

Secondary Outcomes (2)

• Neurothesiometer

  Up to week 5

• Sit and reach test

  Up to week 5

Study Arms (3)

Transcutaneous spinal cord stimulation + Augmented reality Group

EXPERIMENTAL

Other: Transcutaneous spinal cord stimulation Group; Other: Augmented reality

Transcutaneous spinal cord stimulation Group

ACTIVE COMPARATOR

Other: Transcutaneous spinal cord stimulation Group

Augmented reality Group

ACTIVE COMPARATOR

Other: Augmented reality

Interventions

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

Transcutaneous spinal cord stimulation + Augmented reality Group; Transcutaneous spinal cord stimulation Group

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.

Augmented reality Group; Transcutaneous spinal cord stimulation + Augmented reality Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Related Publications (4)

• Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.

  PMID: 35160091 BACKGROUND

• Mekhail NA, Argoff CE, Taylor RS, Nasr C, Caraway DL, Gliner BE, Subbaroyan J, Brooks ES. High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials. 2020 Jan 15;21(1):87. doi: 10.1186/s13063-019-4007-y.

  PMID: 31941531 BACKGROUND

• Stanica IC, Moldoveanu F, Portelli GP, Dascalu MI, Moldoveanu A, Ristea MG. Flexible Virtual Reality System for Neurorehabilitation and Quality of Life Improvement. Sensors (Basel). 2020 Oct 23;20(21):6045. doi: 10.3390/s20216045.

  PMID: 33114272 BACKGROUND

• Alonso-Enriquez L, Gomez-Cuaresma L, Billot M, Garcia-Bernal MI, Benitez-Lugo ML, Casuso-Holgado MJ, Luque-Moreno C. Effectiveness of Virtual Reality and Feedback to Improve Gait and Balance in Patients with Diabetic Peripheral Neuropathies: Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Nov 24;11(23):3037. doi: 10.3390/healthcare11233037.

  PMID: 38063604 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Zahra, DPT

CONTACT

0092 333 4133592; fatimazahra905@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: June 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share