Neuromotor Prosthetic to Treat Stroke-Related Paresis (Cortimo)
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|ClinicalTrials.gov Identifier: NCT03913286|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Complication Stroke Stroke Sequelae Hemiparesis Arm Paralysis||Device: Cortimo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Neuromotor Prosthetic to Treat Stroke-Related Paresis|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
The participant will be implanted with the Blackrock Microsystems MultiPort system.
The Cortimo comprises an implanted brain activity sensor and a wearable powered arm orthosis.
- Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months [ Time Frame: 4 months ]
The Fugl-Meyer assessment is a stroke specific index for estimating the performance of motor function. Total scores of FMA-Upper limb range from 0-66.
From: Fugl-Meyer et al. The post-stroke hemiplegic patient: a method for evaluation of physical performance. Scand. J. Rehabil. Med., 1975.
- Change from Baseline Action Research Arm Test (ARAT) score at 4 months [ Time Frame: 4 months ]
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 4 months [ Time Frame: 4 months ]
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 from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months [ Time Frame: 4 months ]
The Stroke Impact Scales assess how having a stroke impacts a person's life. The scale has 8 subscales which ask questions regarding a person's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time).
From: Duncan et al. The Stroke Impact Scale Version 2.0 : Evaluation of Reliability, Validity, and Sensitivity to Change. Stroke, 1999.
- Change from Baseline "Giving Them A Hand" ADL at 4 months [ Time Frame: 4 months ]
The "Giving Them A Hand" ADL scale measures a person's ability to perform four functional tasks emphasizing proximal movement of the weak arm and some limited movement of the distal areas given a myoelectric elbow-wrist-hand orthosis' capabilities to assist with flexion and extension of the first two fingers. The tasks are: (1) turning on a light switch,(2) lifting a laundry basket bilaterally, (3) bringing a spoon to the mouth, and (4) drinking from a cup. Quality of movement for both grasp and elbow components of each of these is individually rated using a 3-point ordinal scale (where 0 is performs no part of task and 3 is performs normally), and performance of each component is timed with a 120-second limit
From Peters, et al. Giving Them a Hand: Wearing a Myoelectric Elbow-Wrist-Hand Orthosis Reduces Upper Extremity Impairment in Chronic Stroke. Arch. Phys. Med. Rehabil. 2017.
- Change from Baseline Braden skin health score at 4 months [ Time Frame: 4 months ]
The Braden scale predicts pressure sore risk. The Braden score consists of 6 categories: sensory perception, moisture, activity, mobility, nutrition and friction. The score ranges from 6-23 with lower scores indicating a higher risk.
From: Bergstrom et al. The Braden Scale for Predicting Pressure Sore Risk. Nurs. Res. 36(4): 205-210. 1987.
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): NCT03913286
|Contact: Mijail Serruya, MD, PhD||215-955-8922||Mijail.Serruya@jefferson.edu|
|Contact: Erica Jones||215-955-8922||Erica.Jones@jefferson.edu|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Mijail D Serruya, MD, PhD 215-955-8922 Mijail.Serruya@jefferson.edu|
|Principal Investigator:||Mijail Serruya, MD, PhD||Dr.|