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New treatment option for Stroke
Official title Use of Sensory Substitution to Improve Arm Control After Stroke
ClinicalTrials.gov ID: NCT03298243
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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...
- proprioceptive deficit at the elbow in the more involved (contralesional) arm.
You likely can't join if
- Inability of people to give informed consent or follow two-stage instructions.
- people with a bleeding disorder.
- people with fixed contractures or a history of tendon transfer in the involved limb.
- people with a diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any disease that might interfere with neuromuscular function.
- people who are currently using or under the influence of aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with...
- people with a history of epilepsy.
See the full eligibility 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°.
- Inability of people to give informed consent or follow two-stage instructions.
- people with a bleeding disorder.
- people with fixed contractures or a history of tendon transfer in the involved limb.
- people with a diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any disease that might interfere with neuromuscular function.
- people who are currently using or under the influence of aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.
- people 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.
- people with profound atrophy or excessive weakness of muscles in the target area(s) of testing.
- people with a systemic infection.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.