Effectiveness of Active Exploration of Simulated Textures for Sensorimotor Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Episode of stroke confirmed by neuroimaging

More than one month post-stroke

Montreal Cognitive Assessment (MoCA) score ≥ 20

Barthel Index score ≥ 3

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Active Touch Sensory Training InterventionExperimental treatment 1 intervention
Group B: Standard Rehabilitation Without Sensory TrainingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

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