Improving arm control after stroke using sensory feedback
Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke
NA · Marquette University · NCT03298243
This study is testing if using vibrations can help stroke survivors improve control of their weaker arm and if those improvements can help them do everyday tasks better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Marquette University (other) |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT03298243 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance motor control in stroke survivors by using supplemental kinesthetic feedback through vibrotactile stimulation. Thirty participants will undergo training over 24 days to assess improvements in their contralesional arm's functionality. The study has two main objectives: first, to determine if extended training can improve motor control, and second, to see if these skills can generalize to untrained tasks like reaching for objects. Participants will be evaluated through various cognitive and sensorimotor assessments to establish baseline performance and track progress.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors with mild-to-moderate motor impairment and proprioceptive deficits in their contralesional arm.
Not a fit: Patients with severe motor impairment, fixed contractures, or those unable to follow instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve arm functionality and independence for stroke survivors.
How similar studies have performed: While the use of sensory substitution is a novel approach, similar studies have shown promise in improving motor function in stroke rehabilitation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- Marquette University — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Robert A Scheidt, PhD — Marquette University
- Study coordinator: Robert A Scheidt, PhD
- Email: robert.scheidt@marquette.edu
- Phone: (414)288-6124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Proprioceptive Disorders, stroke, proprioception, sensory substitution