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StrokeNCT03298243

Use of Sensory Substitution to Improve Arm Control After Stroke

A study testing Vibrotactile stimulation in people with Stroke and Proprioceptive Disorders, run by Marquette University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Stroke, Proprioceptive Disorders
What is being tested?
Vibrotactile stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
17 Jul 2023to 31 May 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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • stroke survivors who can perform our stabilization and grip modulation tasks and who
  • had a single ischemic or hemorrhagic stroke of the middle cerebral artery (MCA) in the chronic state of recovery (> 6 months post-stroke).
  • ability to give informed consent and be able to follow two-stage instructions.
  • mild-to-moderate motor impairment as assessed using the upper extremity (UE) portion of the Fugl-Meyer Motor Assessment (FM); i.e., UE-FM score between 28 and 50 (inclusive) out of a possible 66.
  • proprioceptive deficit at the elbow in the more involved (contralesional) arm.
  • preserved tactile sensation in either the ipsilesional arm and/or thigh.
  • a minimal active wrist extension of 5°.

Who cannot join

  • Inability of subjects to give informed consent or follow two-stage instructions.
  • subjects with a bleeding disorder.
  • subjects with fixed contractures or a history of tendon transfer in the involved limb.
  • subjects with a diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any disease that might interfere with neuromuscular function.
  • subjects who are currently using or under the influence of aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.
  • subjects with a history of epilepsy.
Show all 12Show fewer
  • history of other psychiatric co-morbidities (e.g. schizophrenia).
  • malignant or benign intra-axial neoplasms.
  • concurrent illness limiting the capacity to conform to study requirements.
  • Cardiac pacemaker, cardiac arrhythmia or history of significant cardiovascular or respiratory compromise.
  • subjects with profound atrophy or excessive weakness of muscles in the target area(s) of testing.
  • subjects with a systemic infection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robert A Scheidt, PhD contact

(414)288-6124

robert.scheidt@marquette.edu

Kimberly D Bassindale, DPT contact

(414)288-6184

kimberly.bassindale@marquette.edu

United States1 site, 1 recruiting
  • Marquette University

    Milwaukee, Wisconsin, 53233

    Robert A Scheidt, PhD, 4142886124, robert.scheidt@marquette.edu

    Kimberly D Bassindale, DPT, 4142886184, nmcl_stroke@marquette.edu

    Recruiting

Other trials in United States

About this study

Official title: Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke

Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass

Read the detailed description

This study has two distinct aims to be addressed in a longitudinal study spanning 24 days.

Aim 1 tests the hypothesis that stroke survivors can improve motor control of their contralesional arm through extended training with supplemental kinesthetic feedback applied to the non-moving arm and hand.

Aim 2 tests the hypothesis that extended training with supplemental kinesthetic feedback can lead to new skills that generalize to untrained reach-to-grasp actions like reaching for a water glass or a book on a shelf.

Day 1: Participants complete baseline tests of cognitive performance over several domains, including psychomotor speed (e.g., Symbol Digit Modalities Test; Digit Copy Test), memory (Rey Auditory Verbal Learning Test; Rey Osterrieth Complex Figure Test), cognitive flexibility/attention shifting (Trail-Making Test B; Wisconsin Card Sort Test), spatial processing (Rey Osterrieth Complex Figure copy test), and action selection/inhibition. (the go, no-go, and stop signal tests).

Day 2: Participants complete baseline tests of sensorimotor impairment and function. Tests of sensorimotor impairment include the upper extremity Fugl-Meyer Assessment for the contralesional arm, two-point discrimination, vibration sensation using a 128 Hz tuning fork, and a robotic test of proprioception in both arms. Motor function in the contralesional arm will be assessed using the Jamar grip strength assessment and the Wolf Motor Function Test.

Day 3: We will test the subjects on their naïve capability to use a 3-Degree-Of-Freedom (3-DOF) vibrotactile display to guide supported (but unconstrained) 3D movements mimicking reach-to-grasp actions like reaching for a water glass or a book on a shelf. The vibrotactile display will provide supplemental kinesthetic feedback of limb movement.

Days 4-23: These 20 sessions train participants on the use of of supplemental kinesthetic feedback of limb movement. We will test two groups of 15 stroke survivors each. Subjects will use supplemental vibrotactile feedback to guide goal-directed reach-to-grasp movements to targets presented visually in 3D space. Individuals assigned to the PROGRESSIVE TRAINING group will practice for several days on interpreting feedback along just one dimension of movement before training to interpret 2 dimensions of feedback. they will conclude training by training to interpret 3D vibrotactile feedback. Individuals assigned to the 3D TRAINING group will only train on the full 3D feedback system.

Day 24: We will re-test the subjects on their capability to use a 3-DOF vibrotactile display to guide supported (but unconstrained) 3D movements mimicking reach-to-grasp actions like reaching for a water glass or a book on a shelf.

Being tested
Vibrotactile stimulation
Keywords
stroke, proprioception, sensory substitution
Medical subject headings
Stroke, Somatosensory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vibrotactile stimulationBehavioural

    Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in off-the-shelf activity monitors.

Study groups in NCT03298243
Study groupRoleWhat they receive
Stroke Cohort - Progressive TrainingExperimentalAim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance
Receives: Behavioral: Vibrotactile stimulation
Stroke Cohort - Whole Task TrainingExperimentalAim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance
Receives: Behavioral: Vibrotactile stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Root Mean Square Kinematic Error

    orthogonal distance between target and hand position during reaching and stabilizing

    Measured: across experimental sessions spanning a typical time frame of 4 to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start17 Jul 2023
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Aims 1 and 2: Parallel-group longitudinal study. Participants will practice reaching to locations in front of them using vibrotactile feedback to guide the precision of the movements. For one group, the tasks will be organized to slowly become more difficult as practice continues. For the other group, the training will only involve the more difficult task. Subjects will be asked to perform simulated tasks of daily living at the beginning or end of practice to test transfer of the vibrotactile training/learning.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298243
Sponsor's protocol ID
HR-3303
Other IDs
1R15HD093086
Status last verified
Sep 2025
First submitted
22 Sep 2017
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krueger AR, Giannoni P, Shah V, Casadio M, Scheidt RA. Supplemental vibrotactile feedback control of stabilization and reaching actions of the arm using limb state and position error encodings. J Neuroeng Rehabil. 2017 May 2;14(1):36. doi: 10.1186/s12984-017-0248-8.

    PubMed 28464891
  • Risi N, Shah V, Mrotek LA, Casadio M, Scheidt RA. Supplemental vibrotactile feedback of real-time limb position enhances precision of goal-directed reaching. J Neurophysiol. 2019 Jul 1;122(1):22-38. doi: 10.1152/jn.00337.2018. Epub 2019 Apr 17.

    PubMed 30995149
  • Shah VA, Casadio M, Scheidt RA, Mrotek LA. Spatial and temporal influences on discrimination of vibrotactile stimuli on the arm. Exp Brain Res. 2019 Aug;237(8):2075-2086. doi: 10.1007/s00221-019-05564-5. Epub 2019 Jun 7.

    PubMed 31175382
  • Shah VA, Casadio M, Scheidt RA, Mrotek LA. Vibration Propagation on the Skin of the Arm. Appl Sci (Basel). 2019 Oct 2;9(20):4329. doi: 10.3390/app9204329. Epub 2019 Oct 15.

    PubMed 34621542
  • Jayasinghe SAL, Sarlegna FR, Scheidt RA, Sainburg RL. The neural foundations of handedness: insights from a rare case of deafferentation. J Neurophysiol. 2020 Jul 1;124(1):259-267. doi: 10.1152/jn.00150.2020. Epub 2020 Jun 24.

    PubMed 32579409
  • Ballardini G, Krueger A, Giannoni P, Marinelli L, Casadio M, Scheidt RA. Effect of Short-Term Exposure to Supplemental Vibrotactile Kinesthetic Feedback on Goal-Directed Movements after Stroke: A Proof of Concept Case Series. Sensors (Basel). 2021 Feb 22;21(4):1519. doi: 10.3390/s21041519.

    PubMed 33671643
  • Jayasinghe SAL, Scheidt RA, Sainburg RL. Neural Control of Stopping and Stabilizing the Arm. Front Integr Neurosci. 2022 Feb 21;16:835852. doi: 10.3389/fnint.2022.835852. eCollection 2022.

    PubMed 35264934
  • Suminski AJ, Doudlah RC, Scheidt RA. Neural Correlates of Multisensory Integration for Feedback Stabilization of the Wrist. Front Integr Neurosci. 2022 May 6;16:815750. doi: 10.3389/fnint.2022.815750. eCollection 2022.

    PubMed 35600223
  • Pomplun E, Thomas A, Corrigan E, Shah VA, Mrotek LA, Scheidt RA. Vibrotactile Perception for Sensorimotor Augmentation: Perceptual Discrimination of Vibrotactile Stimuli Induced by Low-Cost Eccentric Rotating Mass Motors at Different Body Locations in Young, Middle-Aged, and Older Adults. Front Rehabil Sci. 2022 Jul 1;3:895036. doi: 10.3389/fresc.2022.895036. eCollection 2022.

    PubMed 36188929
  • Shah VA, Thomas A, Mrotek LA, Casadio M, Scheidt RA. Extended training improves the accuracy and efficiency of goal-directed reaching guided by supplemental kinesthetic vibrotactile feedback. Exp Brain Res. 2023 Feb;241(2):479-493. doi: 10.1007/s00221-022-06533-1. Epub 2022 Dec 28.

    PubMed 36576510
  • Mazorow RN, Rayes RK, Flores J, Guidarelli GH, Bassindale KD, Scheidt RA. Utility and User Experience with 3-Dimensional Vibrotactile Kinesthetic Feedback for Improving Reach-to-Grasp Accuracy and Efficiency After Stroke: A Case Series. Restor Neurol Neurosci. 2026 May;44(2):235-255. doi: 10.1177/09226028261429797. Epub 2026 May 23.

    PubMed 42175809

Questions about this trial

What is this clinical trial studying?

A study testing Vibrotactile stimulation in people with Stroke and Proprioceptive Disorders, run by Marquette University at 1 site in United States.

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 12 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 29 Sep 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 United States. 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 Robert A Scheidt, PhD ((414)288-6124, robert.scheidt@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root Mean Square Kinematic Error (time frame: across experimental sessions spanning a typical time frame of 4 to 6 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 NCT03298243, which also lists 11 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 29 Sep 2025.

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