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Development of a FES Device for Hand Use During Arm Activities Following Stroke

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ClinicalTrials.gov Identifier: NCT03986216
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jun Yao, Northwestern University

Brief Summary:
The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during lifting and reaching. Furthermore, to enable sufficient practice intensity both in the clinic and at home, the investigators propose to develop the ReIn-Hand device with easy-to-use utilities by developing a user-customized forearm/hand orthosis with embedded EMG recording and stimulation electrode. To test the device feasibility, a small clinical trial will be conducted. Information related to the clinical trial will be provided below.

Condition or disease Intervention/treatment Phase
Stroke Hand Function Device: ReIn-Hand device assisted home-based practice Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a small clinical trial to determine the feasibility of the product for the purpose of home-based arm/hand practice. We will recruit 2-4 stroke participants to participate the small clinical trial (i.e., the home based practice).
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Development of a Portable Synergy Resistant EMG-driven FES Device for Intuitive Control of Grasp and Release During Functional Arm Activities Following Stroke
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Home based group
This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks.
Device: ReIn-Hand device assisted home-based practice
Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device




Primary Outcome Measures :
  1. Change from Baseline Box and Blocks Test (BBT) Score across the 12 weeks of the intervention, immediately after conclusion of intervention, and 3 months post-intervention [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimensions by means of a partition. One hundred and fifty small wooden cubes or blocks are placed in one compartments or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one minute trial period. Patients hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time count as a single point.


Secondary Outcome Measures :
  1. Change in Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    The Fugl-Meyer Assessment of Motor Recovery after stroke evaluates and measures recovery in post-stroke hemiplegic patients. It is used in both the clinical and research settings, and is one of the most widely used quantitative measures of motor impairment. Areas of assessment include activities of daily living, functional mobility, and pain. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the movement. Scores range from 0-66, with 0 and 66 representing no and normal residual upper extremity motor function, respectively.

  2. Change in Quantitative measure of hand opening area and closing force [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    Individual will be instructed to rest paretic hand on a cylinder that is covered with an array of pressure sensors (Pressure Profile Systems, Inc., Los Angeles, CA 90045). Furthermore, 5 markers (9x9 mm) with unique optical features will be placed on the tip of the thumb and the 4 fingers. Individual will then be instructed to perform following task in their comfortable pace: 1) resting, 2) maximally open the paretic hand, and 3) maximally close the paretic hand against the cylinder. Position (with an accuracy of 1mm) and angular (with an accuracy at 0.02 degree) information of fingertips will be captured by 2 registered portable Moire Phase Tracking cameras (Metria Innovation, Inc., Wauwatosa, WI); and the flexion force under the 4 fingers and thumb will be measured by the pressure sensors. This will allow for tracking of the hand pentagon area and closing force during intervention.

  3. Change in Sensory Assessment (Stereognosis) [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    The individual will be asked to use their paretic hand to identify a number of everyday items through touch alone. Scores range from 0-24, with 24 indicating full stereognosis function and 0 representing complete absence of stereognosis.

  4. Change in Cutaneous Sensory Touch Threshold using Semmes-Weinstein Monofilaments [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    The monofilament test is a threshold assay used to determine the minimum stimulation that can be felt by a subject. This test is also known as light touch/protective touch/deep pressure testing in the hands. The threshold of detection for human tactile cutaneous receptors has been measured with as low as a few milligrams of force.

  5. Change in Stroke Impact Scale (SIS) [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    The SIS is a 59 item measure of strength, hand function, activities of daily living, mobility, communication, emotion, memory, and participation. Each item is rated in a 5 point scale in terms of difficulty experienced in completing the item, ranging from 1 (could not do it at all) to 5 (not difficult at all).

  6. Change in Action Research Arm Test (ARAT) [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    The ARAT test is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). ARAT is a validated quick (within ten to fifteen minutes) assessment of the paretic arm's functional disabilities, which offers uncomplicated and comprehensive feedback on the function of their arm, hand and fingers. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.

  7. Change in Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    This test evaluate the stage of motor recovery for the paretic hand. Scores range from 0-7, with 7 representing full function of the hand.

  8. Change in Revised Nottingham Sensory Assessment: Kinaesthesia Subscale [ Time Frame: This will be measured pre-intervention (within 1 week prior to intervention), immediately after conclusion of intervention (within 1 week), and at a 3 month follow up ]
    The kinaesthesia subscale measures an individuals ability to sense movement, direction of movement, and position sense at a given joint. The assessment involves the tester initiating passive movement in the individuals affected finger, wrist, elbow, and shoulder; while the individual attempts to match those movement with their opposite extremity. Scores for each joint range from 0-3, with 3 representing intact position, direction, and sense of movement.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 21-80
  • Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (UE FMA in the range of 10-40/66, CMSA_H stage of the hand section <=4)
  • Normal Cognitive ability (MOCA score >=24)
  • Capacity to provide informed consent
  • Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and then to generate some active elbow extension
  • Ability to open hand with a thumb-to-index finger distance ≥4 cm, with the assistance of the ReIn-Hand device with the help of a physical therapist
  • Discharged from all forms of physical rehabilitation
  • Intact skin on the hemiparetic arm

Exclusion Criteria:

  • Motor or sensory impairment in the non-affected limb
  • Any brainstem and/or cerebellar lesion
  • Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
  • History of neurologic disorder other than stroke (Parkinson's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy)
  • Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
  • Using cardiac pacemaker
  • Seizure
  • Severe upper extremity sensory impairment indicated by absent sharp-blunt discrimination on the tactile sensation subscale of the Revised Nottingham Sensory Assessment( the score >=1 on anterior and posterior forearm)
  • Chemo denervation: botulinum toxin injection to any portion of the paretic UE within the last 6 months, or phenol/alcohol injections <12 months before participation
  • Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods
  • Flexion contractures larger than 30 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP)
  • Pregnant or planning to become pregnant
  • Upper extremity musculoskeletal impairment limiting function prior to stroke.

Information from the National Library of Medicine

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): NCT03986216


Contacts
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Contact: Carolina Carmona, DPT 312-503-4633 ccarmona@northwestern.edu
Contact: Justin Drogos, DPT 312-503-3255 j-drogos@northwestern.edu

Locations
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United States, Illinois
Northwestern University, Dept. of PTHMS Recruiting
Chicago, Illinois, United States, 60611
Contact: Ray Arceo, BS    312-908-0847    ray.arceo@northwestern.edu   
Contact: Carolina Carmona, DPT    312-503-4633    ccarmona@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Jun Yao, PhD Department of Physical Therapy and Human Movement Sciences, Northwestern University

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Responsible Party: Jun Yao, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03986216     History of Changes
Other Study ID Numbers: STU00072008
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jun Yao, Northwestern University:
Stroke rehabilitation
Hand opening
Functional electrical stimulation
Home-based intervention
Task-specific practice
Device-assisted practice

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases