Effectiveness of Active Exploration of Simulated Textures for Sensorimotor Recovery

NCT06962397 | Recruiting

• 1 other identifier: ActiveTouch01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Sensorimotor Impairment Affecting the Upper Limb; Sensory Deficit; Rehabilitation; Tactile Disorders

Keywords

Stroke; Sensorimotor rehabilitation; Tactile stimulation; Upper limb recovery; Electrical stimulation; Virtual textures; Sensory training; Neurorehabilitation; Post-stroke therapy; Active touch paradigm; Functional electrical stimulation; Proprioception; Touch sensitivity; Stroke rehabilitation technology

Outcome Measures

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.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (3)

• Change in Fugl-Meyer Assessment (FMA) Score

  From enrollment to the end of treatment at 2 weeks

• Change in Action Research Arm Test (ARAT) Score

  From enrollment to the end of treatment at 2 weeks

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

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

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.

Device: Active Touch-Based Sensory Training

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.

Interventions

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.

Active Touch Sensory Training Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Federal Center of Cerebrovascular Pathology and Stroke

Moscow, 117997, Russia

RECRUITING

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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).

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29665842 BACKGROUND

• 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.

  PMID: 31396040 BACKGROUND

• 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.

  PMID: 21350049 BACKGROUND

• 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.

  PMID: 29068038 BACKGROUND

• 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.

  PMID: 29689179 BACKGROUND

• 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.

  PMID: 18647725 BACKGROUND

• 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.

  PMID: 30943883 BACKGROUND

• 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.

  PMID: 12883929 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Galina Ivanova, Professor

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

  STUDY CHAIR

Central Study Contacts

Maria Volodina, PhD in Physiology

CONTACT

+79162528715; mariavolodina@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: October 8, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, 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.

Locations

RU (1)