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Finger Movement Training After Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Actuated Virtual Keyboard (AVK) system
Occupational Therapy
Sponsored by
North Carolina State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, FES, virtual reality, rehabilitation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A single, unilateral stroke 2-6 months prior to enrollment Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment Visual capacity to discern specific shapes on the computer screen Capacity to provide informed consent Exclusion Criteria: Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement Hemispatial neglect (as assessed by the Behavioral Inattention Test) Excessive pain in the paretic upper limb (visual analog scale of shoulder pain < 70)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FES + AVK group

    OT Group

    Arm Description

    This group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.

    An occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.

    Outcomes

    Primary Outcome Measures

    Change of Jebsen-Taylor Hand Function Test (JTHFT)
    A standardized and objective measure of fine and gross motor hand function using simulated activities of daily living.

    Secondary Outcome Measures

    Change of Individuated fingertip force
    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.
    Change of Individuated finger movement
    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.
    Change of Muscle activity
    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.
    Change of Lateral pinch strength
    Force produced when the thumb pinches against the radial side of the index finger as if holding a key.
    Change of 3-point pinch strength
    Force produced when thumb pinches against the tips of the index and middle fingers.
    Change of Touch sensitivity
    Touch sensitivity will be measured with von Frey hairs (Aesthesio®).
    Change of Box and Blocks Test (BBT)
    A quick, simple and inexpensive test to measures unilateral gross manual dexterity.
    Change of 9-Hole Peg Test (9PHT)
    A standardized, quantitative assessment used to measure finger dexterity.

    Full Information

    First Posted
    October 11, 2022
    Last Updated
    November 11, 2022
    Sponsor
    North Carolina State University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05621980
    Brief Title
    Finger Movement Training After Stroke
    Official Title
    A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    North Carolina State University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke. The investigators will recruit stroke survivors in the subacute phase of recovery (2-6 months post-stroke). These participants will be involved in a 6-week intervention involving 18 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke, FES, virtual reality, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FES + AVK group
    Arm Type
    Experimental
    Arm Description
    This group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.
    Arm Title
    OT Group
    Arm Type
    Active Comparator
    Arm Description
    An occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.
    Intervention Type
    Device
    Intervention Name(s)
    Actuated Virtual Keyboard (AVK) system
    Intervention Description
    The participant controls an avatar hand by the movement of their own digits. Each avatar digit corresponds to a given virtual key. "Sufficient" digit flexion results in "playing" of that key, with visual and auditory feedback of key strike. Participants will wear a soft exoskeleton, the PneuGlove, with embedded bend sensors to provide real-time measurement of digit flexion. Pneumatic resistance to flexion can be applied to each digit independently, along with extension assistance, through air chambers running through the glove. The FES is intended to assist finger flexion by activating extrinsic finger flexor muscles. A high-density 2×8 stimulation electrode grid will be placed over the median and ulnar nerves at the medial side of the upper arm. The stimulator can deliver electrical stimulation to any pair of electrodes. At the beginning of each session, the investigators will identify the electrode pairs which best produce flexion of each digit with minimal discomfort.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Occupational Therapy
    Intervention Description
    Traditional occupational therapy training sessions.
    Primary Outcome Measure Information:
    Title
    Change of Jebsen-Taylor Hand Function Test (JTHFT)
    Description
    A standardized and objective measure of fine and gross motor hand function using simulated activities of daily living.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Secondary Outcome Measure Information:
    Title
    Change of Individuated fingertip force
    Description
    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of Individuated finger movement
    Description
    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of Muscle activity
    Description
    The participant will will rest each fingertip and thumb tip against a 6-DOF load cell and create individuated fingertip force and finger movement. An electrode array will be placed around the forearm during these tasks to measure muscle activity.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of Lateral pinch strength
    Description
    Force produced when the thumb pinches against the radial side of the index finger as if holding a key.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of 3-point pinch strength
    Description
    Force produced when thumb pinches against the tips of the index and middle fingers.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of Touch sensitivity
    Description
    Touch sensitivity will be measured with von Frey hairs (Aesthesio®).
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of Box and Blocks Test (BBT)
    Description
    A quick, simple and inexpensive test to measures unilateral gross manual dexterity.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.
    Title
    Change of 9-Hole Peg Test (9PHT)
    Description
    A standardized, quantitative assessment used to measure finger dexterity.
    Time Frame
    Change of value from before the intervention to immediately after the intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A single, unilateral stroke 2-6 months prior to enrollment Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment Visual capacity to discern specific shapes on the computer screen Capacity to provide informed consent Exclusion Criteria: Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement Hemispatial neglect (as assessed by the Behavioral Inattention Test) Excessive pain in the paretic upper limb (visual analog scale of shoulder pain < 70)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Derek G Kamper, PhD
    Phone
    7735201233
    Email
    dgkamper@ncsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad Ghassemi, PhD
    Phone
    3125365014
    Email
    mghasse@ncsu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    In accordance with the specifications and limitations outlined by the Institutional Review Boards at North Carolina State University and the University of North Carolina at Chapel Hill, behavioral and performance data will be made available to other investigators upon request.
    IPD Sharing Time Frame
    The deidentified data will become available after the completion of the study and remain available for three years.
    IPD Sharing Access Criteria
    Data will be made available to other researchers for scientific purposes.
    Citations:
    PubMed Identifier
    20378482
    Citation
    Connelly L, Jia Y, Toro ML, Stoykov ME, Kenyon RV, Kamper DG. A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. IEEE Trans Neural Syst Rehabil Eng. 2010 Oct;18(5):551-9. doi: 10.1109/TNSRE.2010.2047588. Epub 2010 Apr 8.
    Results Reference
    background
    PubMed Identifier
    25542201
    Citation
    Thielbar KO, Lord TJ, Fischer HC, Lazzaro EC, Barth KC, Stoykov ME, Triandafilou KM, Kamper DG. Training finger individuation with a mechatronic-virtual reality system leads to improved fine motor control post-stroke. J Neuroeng Rehabil. 2014 Dec 26;11:171. doi: 10.1186/1743-0003-11-171.
    Results Reference
    background
    PubMed Identifier
    30440660
    Citation
    Shin H, Hu X. Flexibility of Finger Activation Patterns Elicited through Non-invasive Multi-Electrode Nerve Stimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:1428-1431. doi: 10.1109/EMBC.2018.8512479.
    Results Reference
    background

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    Finger Movement Training After Stroke

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