tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy
2026年6月1日 更新者：Riphah International University
Combined Effects of Transcutaneous Spinal Cord Stimulation (tSCS) and Augmented Reality (AR) Training on Pain and Balance in Diabetic Neuropathy Patients.
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mirza Obaid Baig, MSPT
- 电话号码：00923332238706
- 邮箱：obaid.baig@riphah.edu.pk
研究联系人备份
- 姓名：Mahnoor Imtiaz, DPT
- 电话号码：0092 315 5214237
- 邮箱：mahnoorimtiaz54@gmail.com
学习地点
-
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Punjab Province
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Rawalpindi、Punjab Province、巴基斯坦
- Pakistan Railway Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- More than or equals to 4 score on Douleur Neuropathique 4 Questionnaire
- More than or equals to 6 Hz at Neurothesiometer
- More than or equals to 4 score on the Numeric Pain Rating Scale (NPRS)
Exclusion Criteria:
- Cognitively compromised (MOCA ≤ 26/30)
- Metallic implants at skull
- Shunting
- Skin allergy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Transcutaneous spinal cord stimulation and Augmented Reality Group
|
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.
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.
|
|
有源比较器：Augmented Reality Group
|
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.
|
|
有源比较器：Transcutaneous spinal cord stimulation Group
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
大体时间：Up to week 5 (baseline/week 1/week 5)
|
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.
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Up to week 5 (baseline/week 1/week 5)
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Time Up and Go (TUG)
大体时间：Up to week 5 (Baseline/week 1/week 5)
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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.
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Up to week 5 (Baseline/week 1/week 5)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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30 Second Chair Stand Test
大体时间：Up to week 5 (Baseline/week 1/week 5)
|
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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Up to week 5 (Baseline/week 1/week 5)
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Neurothesiometer
大体时间：Up to week 5 (Baseline/Week 1/week 5)
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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.
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Up to week 5 (Baseline/Week 1/week 5)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mirza Obaid Baig, MSPT、Riphah International University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年1月31日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.