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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Touch Sensory Training Intervention | Experimental | Participants in this arm undergo a novel sensory rehabilitation protocol based on the Active Touch Paradigm. This intervention integrates real-time functional electrical stimulation with voluntary finger movement across a touch-sensitive screen to explore virtual textures of varying densities. Each time a participant's finger crosses an invisible virtual grating line, a tactile sensation is delivered via electrical stimulation to the index finger. The system records finger trajectory, response time, and decision-making accuracy, offering real-time visual and tactile feedback to enhance sensory discrimination and neuroplasticity. The training consists of 180 trials divided into six blocks with breaks in between, and assessments are conducted before and after the intervention using tools such as the Touch-Test monofilament, Fugl-Meyer Assessment, and ARAT. This arm aims to evaluate the efficacy of active engagement and sensorimotor integration in promoting sensory recovery after stroke. |
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| Standard Rehabilitation Without Sensory Training | No Intervention | Participants in this arm receive standard post-stroke rehabilitation as prescribed by their physicians but do not undergo any form of targeted sensory training or participate in the Active Touch Paradigm. They complete the same pre- and post-intervention assessments as the experimental group, including tactile sensitivity testing with von Frey monofilaments, the Fugl-Meyer Assessment, the Action Research Arm Test (ARAT), and the Nine-Hole Peg Test (9HPT). This arm serves as a control condition to evaluate the specific effects of the active touch-based sensory intervention on sensory and motor recovery in stroke survivors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Touch-Based Sensory Training | Device | 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 virtual textures and select the denser one. The stimulation is synchronized with finger movement to ensure real-time sensory feedback. The training consists of 50 trials divided into 5 blocks, and is designed to enhance tactile discrimination and proprioception through sensorimotor integration. The paradigm is interactive, personalized based on individual sensory thresholds, and aims to promote neural plasticity in stroke survivors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tactile Sensitivity of the Affected Index Finger | Tactile sensitivity is assessed using von Frey monofilaments applied to the index finger of the hand contralateral to the stroke lesion. The outcome is defined as the change in sensory threshold (in grams) from baseline to post-intervention. A decrease in threshold indicates improved tactile sensitivity. This measure evaluates the primary therapeutic effect of the active touch-based sensory training. | From enrollment to the end of treatment at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Assessment (FMA) Score | To evaluate potential improvements in upper limb motor function following the Active Touch-based sensory training, participants completed the Fugl-Meyer Assessment (FMA) of Sensorimotor Function before and after the intervention. The FMA is a comprehensive scale that measures motor function, sensory function, balance, and joint range of motion in individuals with neurological conditions. The scale's scores range from a minimum of 0 to a maximum of 226, with higher scores indicating a better outcome, reflecting improved motor and sensory function. Scores were compared between the experimental and control groups to assess the effect of the training on motor recovery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Volodina, PhD in Physiology | Contact | +79162528715 | mariavolodina@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Galina Ivanova, Professor | Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Center of Cerebrovascular Pathology and Stroke | Recruiting | Moscow | 117997 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32742254 | Result | 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. | |
| 37973838 | Result | 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. |
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De-identified individual participant data (IPD) will be made publicly available, including:
Beginning immediately after publication with no end date
Data will be accessible immediately after publication via OSF under a CC-BY 4.0 license, without restrictions. No approval process is required.
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This is a parallel-group, controlled trial. Participants are randomized into two groups. The experimental group receives 10 sessions of active sensory training using programmable electrical stimulation during virtual texture exploration, in addition to standard rehabilitation. The control group receives standard rehabilitation only. Both groups are evaluated pre- and post-intervention.
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| From enrollment to the end of treatment at 2 weeks |
| Change in Action Research Arm Test (ARAT) Score | The Action Research Arm Test (ARAT) was used to assess fine and gross motor function of the upper limb. The ARAT is a scale specifically designed to evaluate the ability to perform a range of tasks, including grasp, grip, pinch, and gross movement. The ARAT score ranges from a minimum of 0 to a maximum of 57, with higher scores indicating a better outcome, reflecting improved motor function. Changes in ARAT scores before and after the intervention were analyzed to determine whether sensory training contributed to motor recovery in the experimental group. | From enrollment to the end of treatment at 2 weeks |
| Change in Nine-Hole Peg Test (9HPT) Performance | To evaluate changes in manual dexterity, participants performed the Nine-Hole Peg Test at baseline and post-intervention. Task completion time was compared pre- and post-treatment to identify improvements in fine motor skills potentially attributable to the active touch training. | From enrollment to the end of treatment at 2 weeks |
| Result | 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). |
| 21798714 | Result | 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. |
| 22561099 | Result | 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. |
| 20729650 | Result | 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. |
| 35329318 | Result | 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. |
| 34225764 | Result | 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. |
| 29665842 | Result | Carlsson H, Rosen B, Pessah-Rasmussen H, Bjorkman A, Brogardh C. SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial. Trials. 2018 Apr 17;19(1):229. doi: 10.1186/s13063-018-2628-1. |
| 31396040 | Result | Turville ML, Walker J, Blennerhassett JM, Carey LM. Experiences of Upper Limb Somatosensory Retraining in Persons With Stroke: An Interpretative Phenomenological Analysis. Front Neurosci. 2019 Jul 24;13:756. doi: 10.3389/fnins.2019.00756. eCollection 2019. |
| 21350049 | Result | Carey L, Macdonell R, Matyas TA. SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation: a randomized controlled trial. Neurorehabil Neural Repair. 2011 May;25(4):304-13. doi: 10.1177/1545968310397705. Epub 2011 Feb 24. |
| 29068038 | Result | Carlsson H, Gard G, Brogardh C. Upper-limb sensory impairments after stroke: Self-reported experiences of daily life and rehabilitation. J Rehabil Med. 2018 Jan 10;50(1):45-51. doi: 10.2340/16501977-2282. |
| 29689179 | Result | Carey LM, Matyas TA, Baum C. Effects of Somatosensory Impairment on Participation After Stroke. Am J Occup Ther. 2018 May/Jun;72(3):7203205100p1-7203205100p10. doi: 10.5014/ajot.2018.025114. |
| 18647725 | Result | Sullivan JE, Hedman LD. Sensory dysfunction following stroke: incidence, significance, examination, and intervention. Top Stroke Rehabil. 2008 May-Jun;15(3):200-17. doi: 10.1310/tsr1503-200. |
| 30943883 | Result | Kessner SS, Schlemm E, Cheng B, Bingel U, Fiehler J, Gerloff C, Thomalla G. Somatosensory Deficits After Ischemic Stroke. Stroke. 2019 May;50(5):1116-1123. doi: 10.1161/STROKEAHA.118.023750. |
| 12883929 | Result | Nowak DA, Hermsdorfer J, Topka H. Deficits of predictive grip force control during object manipulation in acute stroke. J Neurol. 2003 Jul;250(7):850-60. doi: 10.1007/s00415-003-1095-z. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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