NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

NCT04798378 | Active Not Recruiting FDA Device

• 1 other identifier: Neurosleeve 20D.372
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neurologic Diseases; Hemiparesis; Quadriplegia; Muscular Dystrophies; Arthrogryposis; Spinal Cord Injuries; Charcot-Marie-Tooth; Stroke; Weakness of Extremities as Sequela of Stroke; Weakness Due to Upper Motor Neuron Dysfunction; Amyotrophic Lateral Sclerosis; Spinal Muscular Atrophy; Arm Paralysis; Cerebral Palsy

Keywords

Arm weakness, paralysis; orthosis; functional electrical stimulation; brace

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Change from Baseline Action Research Arm Test (ARAT) score at 8 weeks

  8 Weeks

Other Outcomes (3)

• Change from Baseline Motricity Index score at 8 weeks

  8 weeks

• Change in ABILHAND-Kids questionnaire score at 8 weeks (for participants aged < 18)

  8 weeks

• Change in Box and Blocks score at 8 weeks

  8 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

Neurosleeve DEVICE

Myoelectric devices for restoration of independent arm function

Treatment Arm

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have weakness in one or both arms such that flexion or extension of the wrist, elbow or shoulder are 3/5 or less on the Manual Muscle Testing Scale
• The etiology of weakness is due to a neurological disease or injury or orthopedic condition that occurred 6 or more months ago
• Participant is willing to comply with trial instructions
• Adult participant is able to provide informed consent prior to enrollment in the study, and for children, child is able to provide assent and designated caregiver (parent or guardian) is able to provide informed consent
• The participant is fluent in English and, if the participant were a child, at least one parent/guardian were fluent in English
• Medically stable and living at home in the community.
• No joint contracture, spasticity or other limitations to range of motion in the affected lower limb(s) precluding the operation of a wearable, powered orthotic device on the arm
• Sufficient sitting balance to sit in a chair
• 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)

You may not qualify if:

• Orthopedic conditions of either arm that would affect performance on study
• Untreated psychiatric or neurologic disturbances that would affect motivation and trial participation
• Excessive pain in one or both of the arms (\> 5 on a 10-point visual analog scale)
• Excessive spasticity at one or both arms, as defined as a score of \> 2 on the Modified Ashworth Spasticity Scale
• Advice from any of the participant's health providers that upper extremity powered orthotics or electrical stimulation were contra-indicated
• Presence of an implanted medical device in the body (such as cardiac pacemaker, implanted defibrillator, metallic device)
• Metal implants or exposed metal in the weak or paralyzed arm
• Lack of access to internet or wireless coverage to enable telemedicine-guided sessions
• Any history of alcohol or other substance use
• Other conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation, including severe skin conditions, and/or other sequelae that may be contraindicated for using a powered orthotic or using electrical stimulation, as well as personal circumstances

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Nemours Children's Hospital

Wilmington, Delaware, 19803, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Khantan M, Avery M, Aung PT, Zarin RM, Hammelef E, Shawki N, Serruya MD, Napoli A. The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. J Neuroeng Rehabil. 2023 Aug 4;20(1):103. doi: 10.1186/s12984-023-01228-2.

  PMID: 37542335 DERIVED

Related Links

• Neurorestoration laboratory web page

MeSH Terms

Conditions

Nervous System Diseases; Paresis; Quadriplegia; Muscular Dystrophies; Arthrogryposis; Spinal Cord Injuries; Charcot-Marie-Tooth Disease; Stroke; Amyotrophic Lateral Sclerosis; Muscular Atrophy, Spinal; Cerebral Palsy; Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Damage, Chronic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: April 16, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (2)