Recruiting

Sensory Substitution

Sponsor:

Marquette University

Code:

NCT03298243

Conditions

Stroke

Proprioceptive Disorders

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Vibrotactile stimulation

Study Details

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

Study ID

NCT03298243

Start date

Jul 17, 2023

Status verified date

Sep, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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°.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Stroke Cohort - Progressive Training

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

experimental: Stroke Cohort - Whole Task Training

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

Interventions

Vibrotactile stimulation

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

Primary outcome measure

  • Root Mean Square Kinematic Error [ Time Frame: across experimental sessions spanning a typical time frame of 4 to 6 weeks ]

Central Contacts and Locations

Central contacts

Robert A Scheidt, PhD

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

Kimberly D Bassindale, DPT

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

Locations

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Robert A Scheidt, PhD

4142886124robert.scheidt@marquette.edu

Kimberly D Bassindale, DPT

4142886184nmcl_stroke@marquette.edu

More Information

Sponsor

Marquette University

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • stroke
  • proprioception
  • sensory substitution

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Marquette University on 2025-09-29.