An interventional study of Neurosleeve in Neurologic Diseases, Hemiparesis and Quadriplegia, sponsored by Thomas Jefferson University. Active, not recruiting at 2 sites in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Supportive care
The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined powered arm brace (orthosis) and muscle stimulation system to help restore movement in one arm sufficient to perform daily activities. This study could lead to the development of a product that could allow people with arm weakness or arm paralysis to use the NuroSleeve and similar devices to improve arm health and independent function.
People can develop arm weakness due to stroke and other neurological conditions. Portable powered braces and functional electrical stimulation can help restore functional arm movement in these individuals. Powered braces and muscle stimulation may be triggered by detecting movement or electrical activity of proximal muscles that the person still can control. The overall objective of this study is to establish that children and adults with chronic, stable neurological motor impairment can achieve voluntary control over the NuroSleeve upper extremity orthosis and functional electrical stimulation system, and that they can use this voluntary control to perform functionally beneficial tasks to enhance independence, mental and physical health. While myoelectric prostheses have been studied for decades in children with limb loss, it is necessary to gather pilot data on the use of orthoses with optional electrical stimulation in people with intact yet paralyzed limbs. These adults and children have persistent motor deficits even after intensive physical and occupational therapy. The NuroSleeve and similar devices could help all people who have arm weakness.
757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.
This study's planned enrollment of 20 is below the median of 55 across 495 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:• Must be 4 years or older
Exclusion Criteria:• Visual impairment such that following visually-guided instructions would be challenging even with ordinary corrective lenses
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will received a customized NuroSleeve and undergo 8 weeks of occupational therapy using the NuroSleeve (135 minutes per week for 8 weeks: this can be done as 45 minutes three times per week, 68 minute sessions twice per week, or one 135 minute once per week).
Device: Neurosleeve
Myoelectric devices for restoration of independent arm function
Change in Canadian Occupational Performance Measure score at 8 weeks
The Canadian Occupational Performance Measure (COPM) is an individualized measure designed for use by occupational therapists to detect self-perceived change in occupational performance problems over time. From Law et al., 2000.
Time frame: 8 weeks
Change from Baseline Action Research Arm Test (ARAT) score at 8 weeks
The Action Research Arm Test (ARAT) measures specific changes in the arm function in people who sustained cerebral damage resulting in arm weakness. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch and gross movements. Each sub scale has items ordered according to ascending difficulty: 0- can not perform any part of the test, 1- performs the test partialy, 2- completes the test, but takes abnormally long time, 3- performs the test normally. The sum of all subscales are added to compute the total score. The total score ranges between 0 to 57. The higher score is considered to be better outcome. From: Yozbatiran et al. A standardized approach to performing the action research arm test. Neurorehabil. Neural Repair, 2008.
Time frame: 8 Weeks
Change from Baseline Motricity Index score at 8 weeks
The Motricity Index measures strength in the arms and legs after stroke. The weighted score is based on the ordinal 6 point scale of Medical Research Council to measure maximal isometric muscle strength. From: Collin and Wade. Assessing motor impairment after stroke: A pilot reliability study. J. Neurol. Neurosurg. Psychiatry, 1990.
Time frame: 8 weeks
Change in ABILHAND-Kids questionnaire score at 8 weeks (for participants aged < 18)
The ABILHAND-Kids questionnaire was developed as a measure of manual ability and explores the most representative inventory of manual activities. The 21 items of ABILHAND-Kids defined a valid and reliable manual ability scale.
Time frame: 8 weeks
Change in Box and Blocks score at 8 weeks
The experimented counts how many uniformly sized cubes that can be moved from one half of an opened wooden box, over a partition to the other half of the opened box the participant can move in one minute, This measure reflects dexterity, grasp strength, ability to release, and speed of movement and will be performed while the participant is using the NuroSleeve. From Mathiowetz et al, 1985.
Time frame: 8 weeks
Started Apr 2020 (actual). Primary completion is estimated for Dec 2025, 68 months after the start.
Of 167 non-industry interventional studies with no phase under Nervous System Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 68 months is above that.
Counting every sponsor, half of 193 studies reached it within 30 months; a quarter within 11 and three quarters within 57.
Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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