Comparison of Upper Extremity and Lower Extremity Functio... | NCT04291170

Studies
Comparison of Upper Extremity and Lower Extremity Function and Quick DASH

NCT04291170

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Apr 9, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hand Injuries

Interventions

QDASH
KOOSJR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Logistics (Research Staffing)

Expanded Access Info

Start Date

Sep 2040Estimated

Primary Completion Date

Dec 2040Estimated

Completion Date

Dec 2040Estimated

First Submitted Date

Feb 27, 2020

First Submission Date that Met QC Criteria

Feb 27, 2020

First Posted Date

Mar 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2025

Last Update Posted Date

Apr 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QDASH	Experimental	Completing the tasks on the QuickDASH	Other: QDASH
KOOSJR	Active Comparator	Completing the tasks on the KOOSJR	Other: KOOSJR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QDASH	Other	completing the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood	QDASH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QDASH score	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

new patient
stanford hand surgery clinic patient

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robin N Kamal, MD MBA	Stanford University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided