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I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke

Primary Purpose

Stroke, Upper Extremity Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Additional weight at hand
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Post-stroke
  • Receive regular therapy at Jessa hospital
  • Able to willingly sign informed consent

Exclusion Criteria:

  • Relapse during study
  • Secundary complications limiting upper extremity performance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Added weight to hand

    Arm Description

    Outcomes

    Primary Outcome Measures

    Action Research Arm Test
    Score
    Action Research Arm Test
    Score
    Fugl-Meyer
    Score
    Fugl-Meyer
    Score
    Box and Blocks
    Score
    Box and Blocks
    Score
    Upper extremity kinematics
    Joint angles
    Upper extremity kinematics
    Joint angles

    Secondary Outcome Measures

    Full Information

    First Posted
    January 22, 2020
    Last Updated
    February 10, 2020
    Sponsor
    Maastricht University
    Collaborators
    Jessa Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04265079
    Brief Title
    I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke
    Official Title
    I2-CoRT WTP9 Bovenste Extremiteit Motoriek Interventie Met Hand Orthese Bij Mensen na Een Beroerte
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University
    Collaborators
    Jessa Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The upper extremity kinematics of people post-stroke will be monitored with/without an inactive hand orthosis (intervention: added weight to hand) during ARAT, Fugl-Meyer, and Box and Blocks tests. Measurements will occur right after inclusion and repeated once after 7-8 weeks. Upper extremity kinematics and test scores will indicate the influence of additional weight to hand as a possible confounder when, in the future, the hand orthosis would be used as a therapy tool.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Upper Extremity Dysfunction

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    Study focusses on within participant comparison and cannot be blinded.
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Added weight to hand
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Additional weight at hand
    Intervention Description
    Added weight of an inactive hand orthosis (300 gram)
    Primary Outcome Measure Information:
    Title
    Action Research Arm Test
    Description
    Score
    Time Frame
    0 weeks
    Title
    Action Research Arm Test
    Description
    Score
    Time Frame
    8 weeks
    Title
    Fugl-Meyer
    Description
    Score
    Time Frame
    0 weeks
    Title
    Fugl-Meyer
    Description
    Score
    Time Frame
    8 weeks
    Title
    Box and Blocks
    Description
    Score
    Time Frame
    0 weeks
    Title
    Box and Blocks
    Description
    Score
    Time Frame
    8 weeks
    Title
    Upper extremity kinematics
    Description
    Joint angles
    Time Frame
    0 weeks
    Title
    Upper extremity kinematics
    Description
    Joint angles
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post-stroke Receive regular therapy at Jessa hospital Able to willingly sign informed consent Exclusion Criteria: Relapse during study Secundary complications limiting upper extremity performance

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke

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