- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291170
Comparison of Upper Extremity and Lower Extremity Function and Quick DASH
August 6, 2021 updated by: Robin Kamal, Stanford University
Comparison of Upper Extremity and Lower Extremity Function and Quick DAS
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- new patient
- stanford hand surgery clinic patient
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QDASH
Completing the tasks on the QuickDASH
|
completing the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood
|
Active Comparator: KOOSJR
Completing the tasks on the KOOSJR
|
completing tasks on the KOOSJR: pivot, straighten, go up/down stairs, stand upright, rise from sitting, bend over
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QDASH score
Time Frame: Immediately after completing the taks
|
the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad.
|
Immediately after completing the taks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robin N Kamal, MD MBA, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
August 13, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 55019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
no plan to share IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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