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 range18 Years
SexALL
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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…
What they're measuring
1
Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months
Timeframe: 4 months
2
Change from Baseline Action Research Arm Test (ARAT) score at 4 months
Timeframe: 4 months
3
Change from Baseline Motricity Index score at 4 months
Timeframe: 4 months
4
Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months