Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: a Noninferiority Study

NCT ID: NCT04625244

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2024-04-14

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.

Conditions

Thumb Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: In-person therapy

Standard of care, in-person therapy with a Certified Hand Therapist (CHT)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2: Home therapy program

Participants will be sent video links to three therapy videos demonstrating postoperative recovery exercises, starting 4 weeks after surgery.

Group Type: EXPERIMENTAL

Video assisted home therapy

Intervention Type: OTHER

Subjects will follow along with prerecorded therapy videos.

Interventions

Video assisted home therapy

Subjects will follow along with prerecorded therapy videos.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: collaborator

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Peter J Apel

Orthopedic Hand and Upper Extremity Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter J Apel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic Department of Orthopaedics / Virginia Tech Carilion School of Medicine

Locations

Carilion Clinic Orthopaedic Surgery

Roanoke, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29950288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30702438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31625400 (View on PubMed)

Other Identifiers

20-865

Identifier Type: -

Identifier Source: org_study_id