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NCT Number: NCT06962397

Effectiveness of Active Exploration of Simulated Textures for Sensorimotor Recovery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Center of Cerebrovascular Pathology and Stroke

Moscow, 117997, Russia

Location status: Recruiting

Location contact

Alexei Ossadtchi, Doctor of Sciences

PRINCIPAL_INVESTIGATOR

Alexey Tumialis, PhD

SUB_INVESTIGATOR

Ekaterina Ivanova, MD

SUB_INVESTIGATOR

Galina Ivanova, Professor

CONTACT

[email protected]

Maria Volodina, PhD in Physiology

CONTACT

[email protected]

+79162528715

Maria Volodina, PhD in Physiology

SUB_INVESTIGATOR

Timur Ivanov, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Tactile Sensitivity of the Affected Index Finger

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

Secondary outcomes

  1. Change in Fugl-Meyer Assessment (FMA) Score

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

  2. Change in Action Research Arm Test (ARAT) Score

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

  3. Change in Nine-Hole Peg Test (9HPT) Performance

    Time frame: From enrollment to the end of treatment at 2 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Volodina, PhD in Physiology

CONTACT

[email protected]

+79162528715

Sponsors and collaborators

Lead sponsor

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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