StrokeNCT06962397
Effectiveness of Active Exploration of Simulated Textures for Sensorimotor Recovery
A study testing Active Touch-Based Sensory Training in people with Stroke and Sensorimotor Impairment Affecting the Upper Limb, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Sensorimotor Impairment Affecting the Upper Limb, Sensory Deficit
- What is being tested?
- Active Touch-Based Sensory Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 8 Oct 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal Center of Cerebrovascular Pathology and Stroke
Moscow, 117997
Galina Ivanova, Professor, reabilivanova@mail.ru
Maria Volodina, PhD in Physiology, +79162528715, mvolodina@hse.ru
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Stroke, Sensorimotor Impairment Affecting the Upper Limb, Sensory Deficit, Rehabilitation, Tactile Disorders
- Being tested
- Active Touch-Based Sensory Training
- 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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Touch-Based Sensory TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start8 Oct 2024
- Primary completion1 Jun 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galina Ivanova, Professor, Study chair, Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962397
- Sponsor's protocol ID
- ActiveTouch01
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32742254Oh 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.
PubMed 37973838Elbalawy, 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).
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.
PubMed 21798714Sullivan 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.
PubMed 22561099Stein 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.
PubMed 20729650Carlsson 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.
PubMed 35329318Carlsson 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.
PubMed 34225764Carlsson 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.
PubMed 29665842Turville 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.
PubMed 31396040Carey 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.
PubMed 21350049Carlsson 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.
PubMed 29068038Carey 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.
PubMed 29689179Sullivan 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.
PubMed 18647725Kessner 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.
PubMed 30943883
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06962397
- Acronym / sponsor ID
- ActiveTouch01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Touch Sensory Training Intervention | Experimental | Device: Active Touch-Based Sensory TrainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Touch-Based Sensory TrainingThis 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. | Device | Active Touch Sensory Training Intervention |
Primary outcome
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.
3 secondary outcomes
Change in Fugl-Meyer Assessment (FMA) Score
Time frame: From enrollment to the end of treatment at 2 weeks
Change in Action Research Arm Test (ARAT) Score
Time frame: From enrollment to the end of treatment at 2 weeks
Change in Nine-Hole Peg Test (9HPT) Performance
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Results publication: PubMed 32742254Kapadia 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.
- Results publication: PubMed 37973838Oh 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.
- Results publicationElbalawy, 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).
- Results publication: PubMed 21798714Jerosch-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.
- Results publication: PubMed 22561099Sullivan 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.
- Results publication: PubMed 20729650Stein 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.
- Results publication: PubMed 35329318Carlsson 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.
- Results publication: PubMed 34225764Carlsson 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.
- Results publication: PubMed 29665842Carlsson 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.
- Results publication: PubMed 31396040Turville 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.
- Results publication: PubMed 21350049Carey 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.
- Results publication: PubMed 29068038Carlsson 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Galina Ivanova, Professor study chair
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Touch-Based Sensory Training in people with Stroke and Sensorimotor Impairment Affecting the Upper Limb, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Volodina, PhD in Physiology (+79162528715, mariavolodina@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tactile Sensitivity of the Affected Index Finger (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06962397, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.