Clinical trial NCT04625244: Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: a Noninferiority Study
Official title: Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: a Noninferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Keywords: video assisted therapy
CMC arthroplasty
carpometacarpal arthroplasty
thumb surgery
hand surgery
home therapy
self directed therapy
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2020-11-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate a video assisted, home therapy program where participants complete hand therapy on their own following thumb arthroplasty. In this program, participants will receive prerecorded informational videos. Half of the participants in this study will do standard of care, in-person therapy. The other half will be enrolled in the home therapy program. Participants will fill out an assessment of their physical ability before surgery and again three months after surgery. These assessments will be compared between groups. The study team hypothesizes that the video-assisted, home therapy program will be noninferior to traditional in-person therapy.

Detailed description: Current postoperative hand therapy regimens can be burdensome to patients and non-compliance rates are high. Our service area has a lack of hand therapists in the rural areas and the most common barrier to receiving care is access and transportation. In-person therapy requires patients to have significant flexibility in transportation, work schedule and childcare. Travel time and distances put patients who are already disadvantaged at an increased risk of failed treatment. Furthermore, our hand therapy clinics have high utilization after first CMC arthroplasty (thumb joint replacement) procedures, for which therapy is protocol-driven and results are predictable-two aspects that lend this procedure to amenable results from a virtual, unsupervised program.

This study's central hypothesis is that video assisted therapy can be used in postoperative hand therapy without a change in subject outcomes. In this study, the investigators choose to study therapy for one of the most common postoperative diagnoses seen in Carilion Clinic's hand therapy clinics: thumb arthroplasty (replacement of a thumb joint).

Specific Aim 1 is to determine if a video-assisted, home therapy program (pre-recorded instructional videos) can effectively replace in-person occupational therapy for thumb arthroplasty.

Hypothesis: Outcomes of a therapy program consisting of pre-recorded instructional videos will be noninferior to the standard of care regimen for thumb arthroplasty.

The significance of this study is that it investigates a home therapy solution that the investigators expect to increase access to healthcare in rural populations. This study is novel because it will be the first prospective, randomized control trial to investigate the utility of video-assisted home therapy following hand surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective carpometacarpal (CMC) arthroplasty (CPT code 25447)
* Access to a cellphone, tablet or home computer that is connected to internet and has a 5.5" or larger screen

Exclusion Criteria:

* Bilateral procedures
* Revision procedures
* All concomitant procedures, except MCP fusion, CTS release, and thumb trigger finger release
* Artificial CMC joint replacement
* Inability to provide informed consent for the study
* Non-native English speakers

Primary outcomes:
measure: Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.
timeFrame: Change from baseline to Day 90 after surgery.
Secondary outcomes:
measure: Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.
timeFrame: Change from baseline to Day 365 after surgery.
measure: Pain interference, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 1.0 Pain Interference 6a.
timeFrame: Change from baseline to Day 90 after surgery.
measure: Pain interference, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 1.0 Pain Interference 6a.
timeFrame: Change from baseline to Day 365 after surgery.
measure: Grip strength
timeFrame: Change from baseline to Day 90 after surgery.
measure: Key pinch strength
timeFrame: Change from baseline to Day 90 after surgery.
measure: 3-finger pinch strength
timeFrame: Change from baseline to Day 90 after surgery.
measure: Thumb radial abduction
timeFrame: Change from baseline to Day 90 after surgery.
measure: Thumb palmer abduction
timeFrame: Change from baseline to Day 90 after surgery.
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic Orthopaedic Surgery
state: Virginia
Study officials:
affiliation: Carilion Clinic Department of Orthopaedics / Virginia Tech Carilion School of Medicine
name: Peter J Apel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE. An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing. J Med Internet Res. 2018 Jun 27;20(6):e10457. doi: 10.2196/10457.
citation: Hoogland J, Wijnen A, Munsterman T, Gerritsma CL, Dijkstra B, Zijlstra WP, Annegarn J, Ibarra F, Zijlstra W, Stevens M. Feasibility and Patient Experience of a Home-Based Rehabilitation Program Driven by a Tablet App and Mobility Monitoring for Patients After a Total Hip Arthroplasty. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e10342. doi: 10.2196/10342.
citation: Lee DJ, Calfee RP. The Minimal Clinically Important Difference for PROMIS Physical Function in Patients With Thumb Carpometacarpal Arthritis. Hand (N Y). 2021 Sep;16(5):638-643. doi: 10.1177/1558944719880025. Epub 2019 Oct 18.