- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03779958
Alternatives to Hand Therapy for Hand Surgery Patients
July 30, 2021 updated by: Robin Kamal, Stanford University
Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Patients who are undergoing the included procedures will be informed of the study & consented.
They will be given information on how to download the app & input their surgery date.
The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Redwood City, California, United States, 94063
- Stanford Health Care
-
-
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
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients presenting to a single hand surgery clinic
Description
Inclusion Criteria:
- patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation
- smart phone that is compatible with the app
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities
|
a mobile app that demonstrates hand therapy exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QuickDASH
Time Frame: once a week for 6 weeks
|
The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand.
it is scored 0-100, with higher scores indicating higher disability
|
once a week for 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Specific Functional Scale
Time Frame: once a week for 6 weeks
|
the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability.
|
once a week for 6 weeks
|
VAS Pain
Time Frame: once a week for 6 weeks
|
VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain
|
once a week for 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robin N Kamal, MD, 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 (Actual)
January 12, 2019
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
December 17, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
August 6, 2021
Last Update Submitted That Met QC Criteria
July 30, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neoplasms
- Wounds and Injuries
- Disease
- Cysts
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Mucinoses
- Tendinopathy
- Arm Injuries
- Forearm Injuries
- Tendon Entrapment
- Syndrome
- Carpal Tunnel Syndrome
- Fractures, Bone
- Radius Fractures
- Ganglion Cysts
- Trigger Finger Disorder
Other Study ID Numbers
- 47777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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