tSCS and AR Training on QoL and Physical Activity in Diabetic Neuropathy Patients
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
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：Fatima Zahra, DPT
- 電話番号：0092 333 4133592
- メール：fatimazahra905@gmail.com
参加基準
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
説明
Inclusion Criteria:
- More than or equals to 4 scores on Douleur Neuropathique 4 Questionnaire (DN4)
- More than or equals to 6 Hz at Neurothesiometer
Exclusion Criteria:
- Cognitively compromised (MOCA score ≤ 26/30)
- Metallic implants at skull
- Shunting
- Skin allergy
研究計画
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 |
|---|---|
|
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.
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
|
|
実験的：Transcutaneous spinal cord stimulation + Augmented reality Group
|
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
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.
|
|
アクティブコンパレータ：Augmented reality Group
|
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.
|
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 |
|---|---|---|
|
International Physical Activity Questionnaire
時間枠：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 |
Up to week 5
|
|
Diabetes Quality of Life Questionnaire
時間枠：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
|
Up to week 5
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neurothesiometer
時間枠：Up to week 5
|
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
|
Up to week 5
|
|
Sit and reach test
時間枠：Up to week 5
|
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
|
Up to week 5
|
協力者と研究者
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
一般刊行物
- 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.
- Stanica 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.
- Mekhail 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.
- Alonso-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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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