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Comparison of Upper Extremity and Lower Extremity Function and Quick DASH

Primary Purpose

Hand Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
QDASH
KOOSJR
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hand Injuries

Eligibility Criteria

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

Inclusion Criteria:

  • new patient
  • stanford hand surgery clinic patient

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    QDASH

    KOOSJR

    Arm Description

    Completing the tasks on the QuickDASH

    Completing the tasks on the KOOSJR

    Outcomes

    Primary Outcome Measures

    QDASH score
    the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2020
    Last Updated
    August 6, 2021
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04291170
    Brief Title
    Comparison of Upper Extremity and Lower Extremity Function and Quick DASH
    Official Title
    Comparison of Upper Extremity and Lower Extremity Function and Quick DAS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Logistics (Research Staffing)
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    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
    Patient reported outcome measure (PROM) are a method by which to assess outcomes from a patient perspective. The QuickDASH is a commonly used PROM. QDASH was validated against grip strength and ability work, however not against its ability to actually measure what it sets forth to measure (ie: patient's ability to use a hammer, carry a shopping bag, wash a wall, etc). The purpose of this study is to correlate the self-reported QDASH with patients' ability to perform the functions on the QDASH and compare to a control group who completes the task on a lower extremity PROM, KOOS JR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand Injuries

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    QDASH
    Arm Type
    Experimental
    Arm Description
    Completing the tasks on the QuickDASH
    Arm Title
    KOOSJR
    Arm Type
    Active Comparator
    Arm Description
    Completing the tasks on the KOOSJR
    Intervention Type
    Other
    Intervention Name(s)
    QDASH
    Intervention Description
    completing the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood
    Intervention Type
    Other
    Intervention Name(s)
    KOOSJR
    Intervention Description
    completing tasks on the KOOSJR: pivot, straighten, go up/down stairs, stand upright, rise from sitting, bend over
    Primary Outcome Measure Information:
    Title
    QDASH score
    Description
    the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad.
    Time Frame
    Immediately after completing the taks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: new patient stanford hand surgery clinic patient Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robin N Kamal, MD MBA
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan to share IPD

    Learn more about this trial

    Comparison of Upper Extremity and Lower Extremity Function and Quick DASH

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