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Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke

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ClinicalTrials.gov Identifier: NCT04077073
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jun Yao, Northwestern University

Brief Summary:
A large number of post-stroke survivors cannot functionally use their paretic upper extremity (UE). We, therefore, propose to investigate effects of device-assisted practice of activities of daily living (ADL) in a close-to-normal pattern on UE motor recovery in individuals with moderate to severe stroke by measuring intervention-induced changes in clinical outcomes, UE kinematics, and functional and morphologic neuroplasticity. Positive findings may impact current clinical practice by pushing towards implementing device-assisted practice of ADLs and have the potential to benefit a large population.

Condition or disease Intervention/treatment Phase
Stroke Device: ReIn-Hand Device: Robot Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Device-assisted Practice of Activities of Daily Living in a Close-to-normal Pattern on Upper Extremity Motor Recovery in Individuals With Moderate to Severe Stroke
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : September 15, 2024
Estimated Study Completion Date : March 15, 2025

Arm Intervention/treatment
Experimental: ReIn-hand and robot
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load.
Device: ReIn-Hand
ReIn-Hand assists the hand opening
Other Name: ReIn-Hand assisted

Device: Robot
Robot supports the shoulder load
Other Name: Robot support

Active Comparator: ReIn-Hand
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand.
Device: ReIn-Hand
ReIn-Hand assists the hand opening
Other Name: ReIn-Hand assisted




Primary Outcome Measures :
  1. Change in Box and Blocks Test from baseline to 1 week post-intervention [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 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 compartment 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 Quantitative measure of hand opening area and closing force [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 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.

  2. Change in Cutaneous Sensory Touch Threshold using Semmes-Weinstein Monofilaments [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 3 month follow up ]
    The monofilament test is a threshold assay used to determine the minimum stimulation that can be felt by a subject.

  3. Change in Upper extremity Fugl-Meyer Assessment Score [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 3 month follow up. ]
    The Fugl-Meyer Assessment of Motor Recovery after stroke evaluates and measures motor impairment in post-stroke hemiplegic patients. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the required movements. We will use the upper extremity part of FMA, with scores ranging from 0-66, 0 and 66 representing no and normal residual upper extremity motor function, respectively.

  4. Change in Sensory Assessment (Stereognosis) [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 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.

  5. Change in Stroke Impact Scale [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 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 Motor Activity Log [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 3 month follow up. ]
    It is a semi-structured interview to assess arm function. Individuals are asked to rate quality of movement and amount of movement during 30 daily functional tasks., including object manipulation as well as the use of the arm during gross motor activities. Items scored on a 6-point ordinal scale, with 0 representing never and 6 as normal.

  7. Change in Action Research Arm Test (ARAT) [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 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 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.

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

  9. Change in Revised Nottingham Sensory Assessment: Kinaesthesia Subscale [ Time Frame: This will be measured twice pre-intervention (within 1 week prior to intervention), 1 time immediately after conclusion of intervention (within 1 week), and 1 time at the 3 month follow up. ]
    The kinaesthesia subscale measures an individual's 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.

  10. Change in Coupling forces generated by shoulder and elbow while opening hand with or without lifting [ Time Frame: This will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). ]
    This metric quantifies the coupling forces (during hand opening without lifting) or movements (during hand opening and lifting) generated by shoulder and elbow.

  11. Change in Hand pentagon area (HPA) while opening with or without lifting [ Time Frame: This will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). ]
    This metric quantifies the areas formed by the thumb and fingertips during maximally opening the paretic hand with or without lifting.

  12. Change in Laterality Index for the cortical activity related to hand opening [ Time Frame: This will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). ]
    Laterality Index is defined as (LI = (I-C)/(I+C)), where 'I' and 'C' are the current density strengths from the ipsilesional and contralesional sensorimotor cortices (i.e., combined primary sensorimotor and secondary motor cortices). LI reflects the relative contributions of each cerebral hemisphere to the source activity, with a value close to +1 for an ipsilesional source distribution and -1 for a contralesional source distribution.

  13. Change in Cortical activity ratio (CAR) [ Time Frame: This will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). ]
    The cortical activity ratio is defined as the ratio between the sum of the current density strength of nodes in one of the ROIs, to the sum of current density strength of nodes in the whole sensorimotor cortices. The CAR reflects the relative strength from one ROI as normalized by the total combined strength of the 4 ROIs.

  14. Change in Gray matter (GM) density [ Time Frame: This will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). ]
    It quantifies the gray matter density, which in a particular region of the brain appears to correlate positively with various abilities and skills.

  15. Change in Fractional anisotropy (FA) of bilateral cortico-fugal tracks [ Time Frame: This will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). ]
    It quantifies the white matter integrity of the targeted motor descending tracks.



Information from the National Library of Medicine

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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:

  1. Age between 21-80
  2. 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)
  3. Capacity to provide informed consent
  4. Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and to generate some active elbow extension
  5. 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
  6. MRI compatible
  7. Discharged from all forms of physical rehabilitation
  8. Intact skin on the hemiparetic arm
  9. Be tolerate sitting for no less than 1 hour
  10. MOCA score >=23

Exclusion Criteria:

  1. Motor or sensory impairment in the non-affected limb
  2. Any brainstem and/or cerebellar lesion
  3. Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
  4. History of neurologic disorder other than stroke (PD, ALS, MS, TBI, peripheral neuropathy, Amyotrophic lateral sclerosis, spinal cord injury, Dementia)
  5. Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
  6. Using cardiac pacemaker, implanted cardioverter defibrillator, neurostimulation system inside the brain or spinal cord, bone growth box fusion stimulation
  7. Seizure
  8. Severe upper extremity sensory impairment indicated by absent sensation on the tactile sensation subscale (light touch and pressure items) of the Revised Nottingham Assessment of Somato-Sensations (score<4)
  9. Chemo denervation: botulinum toxin, dysport, or Myobloc or phenol block injection to any portion of the paretic UE within the last 6 months, or phenol/alcohol injections <12 months before participation
  10. Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods
  11. Flexion contractures larger than 45 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) of thumb and index finger
  12. Pregnant or planning to become pregnant
  13. Participating in any experimental rehabilitation or drug studies
  14. Inability to attend intervention sessions 3 times a week during 8 weeks, as well as to assessments/evaluations and follow up
  15. Upper extremity musculoskeletal impairment limiting function prior to stroke
  16. Currently using oxygen
  17. Upper limb amputation

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): NCT04077073


Contacts
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Contact: Jun Yao, PhD 312-908-9060 j-yao4@northwestern.edu
Contact: Riegele Arceo 3129080847 riegele.arceo@northwestern.edu

Locations
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United States, Illinois
Northwestern University, Dept. of PTHMS Recruiting
Chicago, Illinois, United States, 60611
Contact: Jun Yao, PhD    312-908-9060    j-yao4@northwestern.edu   
Contact: Riegele Arceo    312-908-0847    riegele.arceo@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Study Documents (Full-Text)

Documents provided by Jun Yao, Northwestern University:
Study Protocol  [PDF] March 28, 2018
Informed Consent Form  [PDF] March 28, 2018


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Responsible Party: Jun Yao, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04077073     History of Changes
Other Study ID Numbers: STU00206913
R01HD095187 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jun Yao, Northwestern University:
stroke rehabilitation
hand opening
flexion synergy
robot assisted treatment
functional electrical stimulation
motor recovery
brain plasticity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases