Diabetic NeuropathyNCT07619755
tSCS and AR Training on QoL and Physical Activity in Diabetic Neuropathy Patients
A study testing Transcutaneous spinal cord stimulation Group and Augmented reality in people with Diabetic Neuropathy, run by Riphah International University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Transcutaneous spinal cord stimulation Group and Augmented reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than or equals to 4 scores on Douleur Neuropathique 4 Questionnaire (DN4)
- More than or equals to 6 Hz at Neurothesiometer
Who cannot join
- Cognitively compromised (MOCA score ≤ 26/30)
- Metallic implants at skull
- Shunting
- Skin allergy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Diabetic Neuropathy
- Being tested
- Transcutaneous spinal cord stimulation Group, Augmented reality
- Keywords
- neuropathy, transcutaneous spinal cord stimulation, quality of life, augmented reality
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulation GroupOther
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 realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous spinal cord stimulation + Augmented reality Group | Experimental | Not described Receives: Other: Transcutaneous spinal cord stimulation Group; Other: Augmented reality |
| Transcutaneous spinal cord stimulation Group | Active comparator | Not described Receives: Other: Transcutaneous spinal cord stimulation Group |
| Augmented reality Group | Active comparator | Not described Receives: Other: Augmented reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to week 5
Secondary outcomes (2)
Neurothesiometer
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
Measured: Up to week 5
Sit and reach test
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
Measured: Up to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619755
- Sponsor's protocol ID
- REC02260 Fatima Zahra
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35160091Mekhail 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.
PubMed 31941531Stanica 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.
PubMed 33114272Alonso-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.
PubMed 38063604
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07619755
- Acronym / sponsor ID
- REC02260 Fatima Zahra
- Conditions
- Diabetic Neuropathy
- Keywords
- neuropathy, transcutaneous spinal cord stimulation, quality of life, augmented reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than or equals to 4 scores on Douleur Neuropathique 4 Questionnaire (DN4)
- More than or equals to 6 Hz at Neurothesiometer
Key exclusion criteria (4 listed)
- Cognitively compromised (MOCA score ≤ 26/30)
- Metallic implants at skull
- Shunting
- Skin allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulation GroupTranscutaneous 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 | Transcutaneous spinal cord stimulation + Augmented reality Group, Transcutaneous spinal cord stimulation Group |
| Augmented realityAR-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. | Other | Augmented reality Group, Transcutaneous spinal cord stimulation + Augmented reality Group |
Primary outcome
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
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
2 secondary outcomes
Neurothesiometer
Time frame: Up to week 5
Sit and reach test
Time frame: Up to week 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 35160091Barss 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.
- Background: PubMed 31941531Mekhail 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.
- Background: PubMed 33114272Stanica 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.
- Background: PubMed 38063604Alonso-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirza Obaid Baig, MSPT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal cord stimulation Group and Augmented reality in people with Diabetic Neuropathy, run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Zahra, DPT (0092 333 4133592, fatimazahra905@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (time frame: Up to week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07619755, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.