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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mirza Obaid Baig, MSPT
- 電話番号：00923332238706
- メール：obaid.baig@riphah.edu.pk
研究連絡先のバックアップ
- 名前：Mahnoor Imtiaz, DPT
- 電話番号：0092 315 5214237
- メール：mahnoorimtiaz54@gmail.com
研究場所
-
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Punjab Province
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Rawalpindi、Punjab Province、パキスタン
- Pakistan Railway Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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アクティブコンパレータ：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.
|
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アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
時間枠：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)
時間枠：Up to week 5 (Baseline/week 1/week 5)
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
30 Second Chair Stand Test
時間枠：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
時間枠：Up to week 5 (Baseline/Week 1/week 5)
|
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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Mirza Obaid Baig, MSPT、Riphah International University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2027年1月31日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。