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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Mirza Obaid Baig, MSPT
- Telefonní číslo: 00923332238706
- E-mail: obaid.baig@riphah.edu.pk
Studijní záloha kontaktů
- Jméno: Fatima Zahra, DPT
- Telefonní číslo: 0092 333 4133592
- E-mail: fatimazahra905@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
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
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Experimentální: 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.
|
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Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
International Physical Activity Questionnaire
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Neurothesiometer
Časové okno: 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
|
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Sit and reach test
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mirza Obaid Baig, MSPT, Riphah International University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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