Hand InjuriesNCT04291170
Comparison of Upper Extremity and Lower Extremity Function and Quick DASH
A study testing QDASH and KOOSJR in people with Hand Injuries, run by Stanford University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- QDASH and KOOSJR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2040to Dec 2040
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new patient
- stanford hand surgery clinic patient
Who cannot join
- -
About this study
Official title: 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.
- Conditions
- Hand Injuries
- Being tested
- QDASH, KOOSJR
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QDASHOther
completing the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood
KOOSJROther
completing tasks on the KOOSJR: pivot, straighten, go up/down stairs, stand upright, rise from sitting, bend over
| Study group | Role | What they receive |
|---|---|---|
| QDASH | Experimental | Completing the tasks on the QuickDASH Receives: Other: QDASH |
| KOOSJR | Active comparator | Completing the tasks on the KOOSJR Receives: Other: KOOSJR |
What is being measured
The primary outcome is the main question the study is designed to answer.
QDASH score
the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad.
Measured: Immediately after completing the taks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study startSep 2040 (estimated)
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Why it stopped: Logistics (Research Staffing)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
- Investigators
- Robin N Kamal, MD MBA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291170
- Sponsor's protocol ID
- 55019
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2020
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Extremity and Lower Extremity Function and Quick DAS
- ClinicalTrials.gov ID
- NCT04291170
- Acronym / sponsor ID
- 55019
- Conditions
- Hand Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics (Research Staffing)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2040 (estimated)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QDASH | Experimental | Other: QDASHCompleting the tasks on the QuickDASH |
| KOOSJR | Active comparator | Other: KOOSJRCompleting the tasks on the KOOSJR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- new patient
- stanford hand surgery clinic patient
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QDASHcompleting the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood | Other | QDASH |
| KOOSJRcompleting tasks on the KOOSJR: pivot, straighten, go up/down stairs, stand upright, rise from sitting, bend over | Other | KOOSJR |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No. no plan to share IPD
Related trials for Hand Injuries
Recruiting
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
Not yet recruiting
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand Fractures
Active, not recruitingPhase 1/2
Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury
Cervical Spinal Cord Injury
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Recruiting
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin N Kamal, MD MBA principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing QDASH and KOOSJR in people with Hand Injuries, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QDASH score (time frame: Immediately after completing the taks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.