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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.
In Pakistan, 26.3% of the population is affected, and DN impacts about 40% of cases, with early signs reducing function. (9-11) Standard care includes glycemic control, medications like duloxetine and pregabalin, topical agents, and modalities such as TENS.
Alongside pain, lower-limb strength declines due to motor axonal degeneration and prolonged disuse, (1) limiting mobility and increasing the risk of falls. Balance impairments are frequent in DN and result from compromised proprioceptive input and impaired postural control mechanisms; (4) these deficits are exacerbated by pain-related inactivity and muscular weakness.
Augmented reality (AR) based rehabilitation delivers multisensory feedback, such as visual, vestibular, and proprioceptive inputs, during interactive, task-specific training. It enhances sensorimotor coordination, dynamic postural stability, and proprioceptive reweighting. AR training can improve balance responses, promote lower-limb engagement, and reinforce accurate proprioceptive input.
The tSCS enabled stepping in individuals with complete motor loss, confirming its impact on lower-limb functional recovery. Additionally, this stimulation frequency targets mechano-sensory pathways associated with vibration sense and is believed to support retention of sensorimotor gains through repeated activation of neuroplastic mechanisms at the spinal and cortical levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous spinal cord stimulation and Augmented Reality Group | Experimental |
| |
| Augmented Reality Group | Active Comparator |
| |
| Transcutaneous spinal cord stimulation Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous spinal cord stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | The Numeric Pain Rating Scale (NPRS) is a quick, 11-point measure (0 = no pain to 10 = worst imaginable) commonly used across clinical and research settings. Recent studies demonstrate test-retest reliability ranging from 0.58 to 0.93 (good to excellent), with moderate evidence for a minimal clinically important difference (MCID) of 1.5-2.5 points. | Up to week 5 (baseline/week 1/week 5) |
| Time Up and Go (TUG) | The TUG test is a simple, clinically validated tool used to assess dynamic balance and functional mobility. It requires an individual to rise from a seated position, walk three meters, turn, return, and sit down. The TUG demonstrated excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging from 0.89 to 0.94 across multiple trials. | Up to week 5 (Baseline/week 1/week 5) |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Second Chair Stand Test | The 30-Second Chair Stand Test is a widely used, performance-based tool for assessing lower-limb strength and functional mobility. Among individuals with type 2 diabetes mellitus, a population commonly affected by diabetic neuropathy, the test has demonstrated excellent reliability. A test-retest intraclass correlation coefficient (ICC) of 0.92, indicating excellent relative reliability. In terms of measurement precision, the standard error of measurement (SEM) was 1.08 repetitions, and the smallest real difference (SRD) was 3 repetitions, reflecting the threshold for clinically meaningful change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahnoor Imtiaz, DPT | Contact | 0092 315 5214237 | mahnoorimtiaz54@gmail.com | |
| Mirza Obaid Baig, MSPT | Contact | 00923332238706 | obaid.baig@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Mirza Obaid Baig, MSPT | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pakistan Railway Hospital | Rawalpindi | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33818600 | Background | Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538. | |
| 37554880 |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| Augmented Reality | Other | 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. |
|
| Up to week 5 (Baseline/week 1/week 5) |
| Neurothesiometer | The neurothesiometer is a non-invasive and reliable instrument used to assess vibration perception threshold (VPT). It has demonstrated excellent reliability, with intra-class correlation coefficients (ICCs) exceeding 0.90, indicating strong measurement consistency. A VPT cut-off value of ≥ 6 Hz is indicative of neuropathy. Owing to its ease of use, objective quantification, and ability to detect subclinical neuropathy, the neurothesiometer is highly valuable in clinical practice. Its superior standardization makes it a preferred method for evaluating protective sensation and vibration loss, particularly in individuals with diabetes. | Up to week 5 (Baseline/Week 1/week 5) |
| Background |
| Lamichhane P, Sukralia S, Alam B, Shaikh S, Farrukh S, Ali S, Ojha R. Augmented reality-based training versus standard training in improvement of balance, mobility and fall risk: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Jun 20;85(8):4026-4032. doi: 10.1097/MS9.0000000000000986. eCollection 2023 Aug. |
| 34244979 | Background | Henson JV, Varhabhatla NC, Bebic Z, Kaye AD, Yong RJ, Urman RD, Merkow JS. Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy: A Systematic Review. Pain Ther. 2021 Dec;10(2):895-908. doi: 10.1007/s40122-021-00282-9. Epub 2021 Jul 10. |
| 34842478 | Background | Strand NH, Burkey AR. Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. J Diabetes Sci Technol. 2022 Mar;16(2):332-340. doi: 10.1177/19322968211060075. Epub 2021 Nov 29. |
| 31693539 | Background | Gylfadottir SS, Christensen DH, Nicolaisen SK, Andersen H, Callaghan BC, Itani M, Khan KS, Kristensen AG, Nielsen JS, Sindrup SH, Andersen NT, Jensen TS, Thomsen RW, Finnerup NB. Diabetic polyneuropathy and pain, prevalence, and patient characteristics: a cross-sectional questionnaire study of 5,514 patients with recently diagnosed type 2 diabetes. Pain. 2020 Mar;161(3):574-583. doi: 10.1097/j.pain.0000000000001744. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |