CompletedNot Applicable

Neuromotor Prosthetic to Treat Stroke-Related Paresis

United States1 participantsStarted 2019-05-01

Plain-language summary

The purpose of the research is to develop a new medical device prototype to restore functional movement of an arm made weak due to a chronic stroke

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be 18 years or older. * Clinical diagnosis of stroke (hemorrhagic or ischemic, cortical or subcortical), confirmed by brain computer tomography or magnetic resonance imaging, that occurred six or more months prior to enrollment * Must have arm weakness due to stroke. * Participant is willing to comply with all follow-up evaluations at the specified times. * Participant is able to provide informed consent prior to enrollment in the study. * The participant is fluent in English. * \> 24 on the Mini Mental Status Examination * Medically stable. * Passive flexion of shoulder in weakened upper extremity with range of \> 30 degrees or more * Passive abduction of shoulder in weakened upper extremity with range of \> 20 degrees or more * Participant must have a caregiver willing to participate in the study who will help provide care for the surgical site. * Must be willing to live at hospital or at nearby hotel for 90-day duration when implantable components were present. * Plateaued post-stroke recovery with complete or incomplete hemiplegia due to stroke in one upper limb, as measured on two serial occasions (at least one month apart) without improvement, by the following standardized functional assessments of the weaker upper extremity, at their worst: * Manual Muscle Testing scores of 0/5 (no movement) or 1/5 (palpable contraction in muscle, without movement) in the biceps (elbow flexion), triceps (elbow extension), wrist flexors, wrist extensors or…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months

Timeframe: 4 months

Change from Baseline Action Research Arm Test (ARAT) score at 4 months

Timeframe: 4 months

Change from Baseline Motricity Index score at 4 months

Timeframe: 4 months

Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months

Timeframe: 4 months

Trial details

NCT IDNCT03913286

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Stroke, Complication trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months

Timeframe: 4 months

Change from Baseline Action Research Arm Test (ARAT) score at 4 months

Timeframe: 4 months

Change from Baseline Motricity Index score at 4 months

Timeframe: 4 months

Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months

Timeframe: 4 months