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Neurosleeve for Arm Weakness/Paralysis

N/A
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No condition (e.g., severe arthritis, central pain) that would interfere with movement of the legs, ability to understand verbal commands and cooperate with test procedures
No condition that would pose a risk to the application of electrical current to the body (e.g., skin conditions or skin breakdown)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is testing a new device that could help people with arm weakness or paralysis to improve arm function.

Who is the study for?
This trial is for individuals aged 4 or older with arm weakness or paralysis due to neurological diseases, injuries, or orthopedic conditions that occurred over 6 months ago. Participants must be medically stable, able to consent (or have a guardian who can), speak English, and follow trial instructions without skin conditions affecting electrical current application. They should not have implanted medical devices, excessive spasticity/pain in arms, metal implants in the affected arm, severe visual impairment even with lenses, untreated psychiatric/neurological issues affecting participation.Check my eligibility
What is being tested?
The NuroSleeve study tests whether a powered brace combined with muscle stimulation can help restore arm movement sufficient for daily activities in people with arm weakness or paralysis. The goal is to develop a device like NuroSleeve to improve independent function and arm health.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device or skin irritation at the site of electrical stimulation. There might also be muscle fatigue due to exercise and possible soreness after use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have any health issues that limit my leg movement or understanding of instructions.
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I don't have any skin conditions that could be worsened by electrical currents.
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I am at least 4 years old.
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I have weakness in one or both arms, making it hard to move my wrist, elbow, or shoulder.
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My arms can move freely without stiffness, preventing me from using a powered brace.
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I can sit up straight in a chair without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Canadian Occupational Performance Measure score at 8 weeks
Secondary outcome measures
Upper arm
Other outcome measures
Change from Baseline Motricity Index score at 8 weeks
Change in ABILHAND-Kids questionnaire score at 8 weeks (for participants aged < 18)
Change in Box and Blocks score at 8 weeks

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,658 Total Patients Enrolled
4 Trials studying Stroke
2,381 Patients Enrolled for Stroke

Media Library

NuroSleeve Powered Brace & Stimulation System (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04798378 — N/A
Stroke Research Study Groups: Treatment Arm
Stroke Clinical Trial 2023: NuroSleeve Powered Brace & Stimulation System Highlights & Side Effects. Trial Name: NCT04798378 — N/A
NuroSleeve Powered Brace & Stimulation System (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04798378 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Thomas Jefferson University
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Desire for left arm hand wrist finger functional use!
PatientReceived no prior treatments
~5 spots leftby Dec 2025