Use of Sensory Substitution to Improve Arm Control After Stroke

NCT03298243 | Recruiting

• 2 other identifiers: HR-33031R15HD093086
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass

Conditions

Stroke; Proprioceptive Disorders

Keywords

stroke; proprioception; sensory substitution

Outcome Measures

Primary Outcomes (1)

• Root Mean Square Kinematic Error

  orthogonal distance between target and hand position during reaching and stabilizing

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

Study Arms (2)

Stroke Cohort - Progressive Training

EXPERIMENTAL

Aim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance

Behavioral: Vibrotactile stimulation

Stroke Cohort - Whole Task Training

EXPERIMENTAL

Aim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance

Behavioral: Vibrotactile stimulation

Interventions

Vibrotactile stimulation BEHAVIORAL

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

Stroke Cohort - Progressive Training; Stroke Cohort - Whole Task Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Marquette University: lead
• Medical College of Wisconsin: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 28464891 BACKGROUND

• 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.

  PMID: 30995149 BACKGROUND

• 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.

  PMID: 31175382 BACKGROUND

• 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.

  PMID: 34621542 BACKGROUND

• 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.

  PMID: 32579409 BACKGROUND

• 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.

  PMID: 33671643 BACKGROUND

• 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.

  PMID: 35264934 BACKGROUND

• 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.

  PMID: 35600223 BACKGROUND

• 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.

  PMID: 36188929 BACKGROUND

• 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.

  PMID: 36576510 BACKGROUND

MeSH Terms

Conditions

Stroke; Somatosensory Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert A Scheidt, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert A Scheidt, PhD

CONTACT

(414)288-6124; robert.scheidt@marquette.edu

Kimberly D Bassindale, DPT

CONTACT

(414)288-6184; kimberly.bassindale@marquette.edu

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 2, 2017
• Study Start: July 17, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)