NCT03298243 · Marquette University
Use of Sensory Substitution to Improve Arm Control After Stroke
What this study is about
Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the treatment group$1. 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Vibrotactile stimulation
Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in off-the-shelf activity monitors.
Primary outcome measures
Root Mean Square Kinematic Error
Time frame: across experimental sessions spanning a typical time frame of 4 to 6 weeks
orthogonal distance between target and hand position during reaching and stabilizing
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Milwaukee, Wisconsin
Collaborators
Medical College of Wisconsin, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2025 · Source of record for eligibility and locations