An interventional study of Active Touch-Based Sensory Training in Stroke, Sensorimotor Impairment Affecting the Upper Limb and Sensory Deficit, sponsored by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active Touch-Based Sensory Training
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.
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.
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.
Time frame: From enrollment to the end of treatment at 2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 2 weeks
Plan to share: Yes — De-identified individual participant data (IPD) will be made publicly available, including: Demographic data (age, sex) Clinical characteristics (stroke diagnosis, time since onset) Baseline and post-intervention scores (MoCA, Barthel Index, FMA, ARAT, 9HPT, monofilament testing) Training performance metrics (accuracy, response times). Data will be deposited on the Open Science Framework (OSF) repository to ensure transparency and facilitate secondary analyses.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Beginning immediately after publication with no end date
Access criteria: Data will be accessible immediately after publication via OSF under a CC-BY 4.0 license, without restrictions. No approval process is required.
Started Oct 2024 (actual). Primary completion is estimated for Jun 2025, 7 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 7 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health