tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy
2026년 6월 1일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
36
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Mirza Obaid Baig, MSPT
- 전화번호: 00923332238706
- 이메일: obaid.baig@riphah.edu.pk
연구 연락처 백업
- 이름: Mahnoor Imtiaz, DPT
- 전화번호: 0092 315 5214237
- 이메일: mahnoorimtiaz54@gmail.com
연구 장소
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Punjab Province
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Rawalpindi, Punjab Province, 파키스탄
- Pakistan Railway Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Transcutaneous spinal cord stimulation and Augmented Reality Group
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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.
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활성 비교기: Augmented Reality Group
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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.
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활성 비교기: Transcutaneous spinal cord stimulation Group
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Numeric Pain Rating Scale (NPRS)
기간: Up to week 5 (baseline/week 1/week 5)
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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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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30 Second Chair Stand Test
기간: Up to week 5 (Baseline/week 1/week 5)
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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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mirza Obaid Baig, MSPT, Riphah International University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2027년 1월 31일
연구 등록 날짜
최초 제출
2026년 4월 30일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
transcutaneous spinal cord stimulation에 대한 임상 시험
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