Effectiveness of Active Exploration of Simulated Textures for Sensorimotor Recovery

Официальное название

Research on the Effectiveness of the Method of Active Examination of Artificially Simulated Textures Generated by Programmable Transcutaneous Electrical Stimulation as a Method of Restoring Sensorimotor Function of the Upper Limbs

Обзор

Parallel-group, single-blinded controlled clinical trial. The study includes people aged 18-80 years, more than one month after stroke, with confirmed diagnosis, MoCA ≥ 20, and Barthel Index ≥ 3. The control group receives standard rehabilitation. The experimental group also receives active sensory training with programmable electrical stimulation to simulate virtual textures. Sensory function was assessed before and after the training using standard tests, including Fugl-Meyer, ARAT, 9HPT, and monofilament testing.

Подробное описание

Stroke is one of the leading causes of long-term disability worldwide. In many cases, it results in persistent sensorimotor deficits in the upper limbs, including reduced tactile sensitivity, poor proprioception, and impaired fine motor skills. These deficits limit independence in daily activities such as grasping, dressing, or using utensils, and reduce the quality of life for stroke survivors.

Sensory rehabilitation is a critical but often under-addressed aspect of post-stroke recovery. Traditional approaches frequently focus on motor function alone, overlooking the importance of sensory input in guiding and refining movement. While methods such as sensory stimulation and retraining have shown some promise, their long-term effectiveness remains inconsistent, and they often lack patient engagement.

The present study investigates the efficacy of a novel method of active sensory rehabilitation based on simulated texture exploration using programmable transcutaneous electrical stimulation. This method is designed to combine active tactile exploration with real-time sensory feedback. Participants use their index finger to explore virtual textures on a tablet screen. Each time the finger crosses a virtual texture line, an electrical pulse is delivered to the finger via surface electrodes. This setup creates the sensation of moving across textures of different densities, which the participant must compare and identify.

The goal is to determine whether this approach improves tactile discrimination and supports motor recovery in the upper limb. The trial is conducted as a parallel-group, single-blinded controlled clinical study. Participants are adults aged 18 to 80 years, at least one month post-stroke, with sufficient cognitive and functional status (MoCA ≥ 20, Barthel Index ≥ 3). Participants are randomly assigned to either a control group or an experimental group.

The control group receives conventional rehabilitation prescribed by their physician.

The experimental group receives the same conventional therapy, plus 10 sessions of active sensory training using the programmable stimulation system.

Each session includes 5 blocks of 10 trials, during which the participant explores and compares pairs of virtual textures. Performance data, such as accuracy and response time, are recorded.

Before and after the intervention period, participants are assessed using standard clinical scales: Fugl-Meyer Assessment (FMA) for motor function, Action Research Arm Test (ARAT), Nine-Hole Peg Test (9HPT) for fine motor skills, Touch-Test monofilaments for tactile sensitivity

Results are expected to provide insight into the role of active sensory engagement in neurorehabilitation and help develop more effective strategies for upper limb recovery after stroke.

Вмешательства

• Устройство Active Touch-Based Sensory Training
  This intervention combines functional electrical stimulation with active tactile exploration of virtual textures. Using a touch-sensitive screen and a programmable functional electrical stimulator (MotionStim 8), participants explore two invisible virtual textures by moving their index finger across the screen. Each time the finger crosses a virtual texture line, an electrical pulse is delivered to the finger, simulating tactile sensation. Participants are asked to compare the density of two vir

Первичные конечные точки

• Change in Tactile Sensitivity of the Affected Index Finger [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (3)

• Change in Fugl-Meyer Assessment (FMA) Score [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Change in Action Research Arm Test (ARAT) Score [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Change in Nine-Hole Peg Test (9HPT) Performance [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Критерии участия

Критерии включения

• Episode of stroke confirmed by neuroimaging
• More than one month post-stroke
• Montreal Cognitive Assessment (MoCA) score ≥ 20
• Barthel Index score ≥ 3
• Ability to understand and follow instructions
• Informed consent for participation and data collection
• Age 18-80 years

Критерии исключения

• Presence of depressive symptoms (HADS-Depression > 11)
• Upper limb paresis score below 35 on the Fugl-Meyer scale
• Sensory impairment score below 3 or above 10 on the Fugl-Meyer scale

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Federal Center of Cerebrovascular Pathology and Stroke — Moscow

Публикации

• Kapadia N, Moineau B, Popovic MR. Functional Electrical Stimulation Therapy for Retraining Reaching and Grasping After Spinal Cord Injury and Stroke. Front Neurosci. 2020 Jul 9;14:718. doi: 10.3389/fnins.2020.00718. eCollection 2020. PMID 32742254
• Oh ZH, Liu CH, Hsu CW, Liou TH, Escorpizo R, Chen HC. Mirror therapy combined with neuromuscular electrical stimulation for poststroke lower extremity motor function recovery: a systematic review and meta-analysis. Sci Rep. 2023 Nov 16;13(1):20018. doi: 10.1038/s41598-023-47272-9. PMID 37973838
• Elbalawy, Y. M., Fahmy, E. M., Taha, S. I., El Sherbini, A. E. H. I., Abdelghany, A. I., & El-Serougy, H. R. (2020). Effect of Sensory Relearning on Sensory and Motor Functions of the Hand in Patients with Carpal Tunnel Syndrome: A Randomized Controlled Clinical Trial. International Journal of Psychosocial Rehabilitation, 24(05).
• Jerosch-Herold C. Sensory relearning in peripheral nerve disorders of the hand: a web-based survey and delphi consensus method. J Hand Ther. 2011 Oct-Dec;24(4):292-8; quiz 299. doi: 10.1016/j.jht.2011.05.002. Epub 2011 Jul 28. PMID 21798714
• Sullivan JE, Hurley D, Hedman LD. Afferent stimulation provided by glove electrode during task-specific arm exercise following stroke. Clin Rehabil. 2012 Nov;26(11):1010-20. doi: 10.1177/0269215512442915. Epub 2012 May 4. PMID 22561099
• Stein J, Hughes R, D'Andrea S, Therrien B, Niemi J, Krebs K, Langone L, Harry J. Stochastic resonance stimulation for upper limb rehabilitation poststroke. Am J Phys Med Rehabil. 2010 Sep;89(9):697-705. doi: 10.1097/PHM.0b013e3181ec9aa8. PMID 20729650
• Carlsson H, Lindgren I, Rosen B, Bjorkman A, Pessah-Rasmussen H, Brogardh C. Experiences of SENSory Relearning of the UPPer Limb (SENSUPP) after Stroke and Perceived Effects: A Qualitative Study. Int J Environ Res Public Health. 2022 Mar 18;19(6):3636. doi: 10.3390/ijerph19063636. PMID 35329318
• Carlsson H, Rosen B, Bjorkman A, Pessah-Rasmussen H, Brogardh C. SENSory re-learning of the UPPer limb (SENSUPP) after stroke: development and description of a novel intervention using the TIDieR checklist. Trials. 2021 Jul 5;22(1):430. doi: 10.1186/s13063-021-05375-6. PMID 34225764

Идентификаторы

NCT: NCT06962397 · ActiveTouch01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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