NuroSleeve Powered Brace & Stimulation System to Restore Arm Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04798378|
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : August 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|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||Device: Neurosleeve||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Myoelectric Devices for Restoration of Independent Arm Function in Children and Adults With Neurological Disease and Injury|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Treatment Arm
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).
Myoelectric devices for restoration of independent arm function
- Change in Canadian Occupational Performance Measure score at 8 weeks [ Time Frame: 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.
- Change from Baseline Action Research Arm Test (ARAT) score at 8 weeks [ Time Frame: 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.
- Change from Baseline Motricity Index score at 8 weeks [ Time Frame: 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.
- Change in ABILHAND-Kids questionnaire score at 8 weeks (for participants aged < 18) [ Time Frame: 8 weeks ]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.
- Change in Box and Blocks score at 8 weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798378
|Contact: Erica Jones||215-503-4042||CenterNR@jefferson.edu|
|United States, Delaware|
|Nemours Children's Hospital||Recruiting|
|Wilmington, Delaware, United States, 19803|
|Contact: Erica Jones, BA 215-503-4042 CenterNR@jefferson.edu|
|Contact: Mena Scavina, DO Mena.Scavina@nemours.org|
|Sub-Investigator: Mena Scavina, DO|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Erica Jones 215-503-4042 CenterNR@jefferson.edu|
|Principal Investigator: Mijail Serruya, MD, PhD|