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The Effects of Attentional Focus on Arm Training in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
upper arm training on the InMotion 2 shoulder robot
Sponsored by
New York Presbyterian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring attentional focus, upper extremity, hemiparesis, stroke

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis of stroke > 6 months
  • moderate to severe arm impairment
  • intact visual scanning and spatial orientation of the affected arm
  • functional cognitive status
  • medically stable

Exclusion Criteria:

  • concurrent occupational or physical therapy for the arm
  • joint contractures at the wrist, forearm, elbow, or shoulder
  • moderate to severe spasticity at the elbow or shoulder
  • presence of other neurological conditions
  • botulinum toxin injection in the affected arm < 3 months prior
  • score of 0/5 on manual muscle test at the elbow or shoulder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    External Focus (EF)

    Internal Focus (IF)

    Arm Description

    Participants received arm training using the InMotion2 robot under external focus practice conditions and instructions. Participants practiced arm reaching by playing a simple video game. EF instructions: "Focus on moving the yellow ball on the screen in a smooth, straight line at a constant speed"; "Move the yellow ball toward the blinking red/orange light"; and "Hit the center of the target and try not to overshoot the target"

    Participants received arm training using the InMotion2 robot without the video game interface. Participants were instructed to think about how they were moving their arm while completing the arm training tasks. IF instructions: "think about how you're moving your arm"; "push your arm away from you"; "pull your arm toward you"; "move your arm to the right/left"

    Outcomes

    Primary Outcome Measures

    Change in coordination at the shoulder and elbow measured by joint independence after arm training assessed start of training, discharge and at follow up.
    kinematic measure of coordination between the shoulder and elbow joint
    Change in quality of arm motion measured by smoothness at the start of arm training, at 4week, and 8 weeks.
    kinematic assessment of arm motion measured by average velocity decided by maximum velocity
    Change in motor impairment of the arm measured by Fugl-Meyer Assessment (FMA) at the start of training, discharge, and follow up.
    performance based assessment of underlying motor impairment of the affected shoulder, elbow, hand after stroke
    Change in motor impairment and functional ability of the arm measured by the Wolf Motor Function Test (WMFT) at start of training, discharge, and follow up.
    performance based assessment of underlying motor impairment and function of the affected arm after stroke

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2016
    Last Updated
    August 31, 2016
    Sponsor
    New York Presbyterian Hospital
    Collaborators
    New York University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02890446
    Brief Title
    The Effects of Attentional Focus on Arm Training in Stroke
    Official Title
    A Randomized Control Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    New York Presbyterian Hospital
    Collaborators
    New York University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compares the effects of an internal versus an external focus of attention on motor training of the affected arm for individuals with stroke. Participants were randomly assigned to either the internal or external focus treatment groups and received 12 sessions of arm training.
    Detailed Description
    Participants were randomized to one of two treatment groups and received upper arm reaching training on the InMotion 2 shoulder robot (12 hourly sessions over four weeks). The external focus group received instructions specifically to pay attention to the task goal--hitting targets on the video game, while the internal focus group was instructed to pay attention to the movement of their arm motions (video game monitor was turned off). Both groups practiced the same arm reaching pattern and were matched for level of arm impairment and training dosage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    attentional focus, upper extremity, hemiparesis, stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    External Focus (EF)
    Arm Type
    Experimental
    Arm Description
    Participants received arm training using the InMotion2 robot under external focus practice conditions and instructions. Participants practiced arm reaching by playing a simple video game. EF instructions: "Focus on moving the yellow ball on the screen in a smooth, straight line at a constant speed"; "Move the yellow ball toward the blinking red/orange light"; and "Hit the center of the target and try not to overshoot the target"
    Arm Title
    Internal Focus (IF)
    Arm Type
    Experimental
    Arm Description
    Participants received arm training using the InMotion2 robot without the video game interface. Participants were instructed to think about how they were moving their arm while completing the arm training tasks. IF instructions: "think about how you're moving your arm"; "push your arm away from you"; "pull your arm toward you"; "move your arm to the right/left"
    Intervention Type
    Behavioral
    Intervention Name(s)
    upper arm training on the InMotion 2 shoulder robot
    Intervention Description
    Both groups practiced shoulder and elbow exercises on a robotic arm device under an external focus or internal focus practice condition. Practiced arm reaching in a clock-like design to facilitate horizontal shoulder flexion, extension, abduction, adduction. 12 sessions--3 times a week for 4 weeks
    Primary Outcome Measure Information:
    Title
    Change in coordination at the shoulder and elbow measured by joint independence after arm training assessed start of training, discharge and at follow up.
    Description
    kinematic measure of coordination between the shoulder and elbow joint
    Time Frame
    baseline, 4 weeks, 8 weeks
    Title
    Change in quality of arm motion measured by smoothness at the start of arm training, at 4week, and 8 weeks.
    Description
    kinematic assessment of arm motion measured by average velocity decided by maximum velocity
    Time Frame
    baseline, 4 weeks, 8 weeks
    Title
    Change in motor impairment of the arm measured by Fugl-Meyer Assessment (FMA) at the start of training, discharge, and follow up.
    Description
    performance based assessment of underlying motor impairment of the affected shoulder, elbow, hand after stroke
    Time Frame
    baseline, 4 weeks, 8 weeks
    Title
    Change in motor impairment and functional ability of the arm measured by the Wolf Motor Function Test (WMFT) at start of training, discharge, and follow up.
    Description
    performance based assessment of underlying motor impairment and function of the affected arm after stroke
    Time Frame
    baseline, 4 weeks, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of stroke > 6 months moderate to severe arm impairment intact visual scanning and spatial orientation of the affected arm functional cognitive status medically stable Exclusion Criteria: concurrent occupational or physical therapy for the arm joint contractures at the wrist, forearm, elbow, or shoulder moderate to severe spasticity at the elbow or shoulder presence of other neurological conditions botulinum toxin injection in the affected arm < 3 months prior score of 0/5 on manual muscle test at the elbow or shoulder

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24054892
    Citation
    Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.
    Results Reference
    background
    PubMed Identifier
    20078758
    Citation
    Wulf G, Shea C, Lewthwaite R. Motor skill learning and performance: a review of influential factors. Med Educ. 2010 Jan;44(1):75-84. doi: 10.1111/j.1365-2923.2009.03421.x.
    Results Reference
    background
    PubMed Identifier
    12125827
    Citation
    Fasoli SE, Trombly CA, Tickle-Degnen L, Verfaellie MH. Effect of instructions on functional reach in persons with and without cerebrovascular accident. Am J Occup Ther. 2002 Jul-Aug;56(4):380-90. doi: 10.5014/ajot.56.4.380.
    Results Reference
    background
    PubMed Identifier
    23796803
    Citation
    Durham KF, Sackley CM, Wright CC, Wing AM, Edwards MG, van Vliet P. Attentional focus of feedback for improving performance of reach-to-grasp after stroke: a randomised crossover study. Physiotherapy. 2014 Jun;100(2):108-15. doi: 10.1016/j.physio.2013.03.004. Epub 2013 Jun 21.
    Results Reference
    background
    PubMed Identifier
    11765737
    Citation
    Wulf G, McNevin N, Shea CH. The automaticity of complex motor skill learning as a function of attentional focus. Q J Exp Psychol A. 2001 Nov;54(4):1143-54. doi: 10.1080/713756012.
    Results Reference
    background
    PubMed Identifier
    28652064
    Citation
    Kim GJ, Hinojosa J, Rao AK, Batavia M, O'Dell MW. Randomized Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke. Arch Phys Med Rehabil. 2017 Oct;98(10):1924-1931. doi: 10.1016/j.apmr.2017.06.005. Epub 2017 Jun 24.
    Results Reference
    derived

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    The Effects of Attentional Focus on Arm Training in Stroke

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