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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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).

0 / 6Eligibility criteria met