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

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.

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Other: Video assisted home 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.

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linsen T Samuel, MD; Phone Number: 540-521-1474; Email: ltsamuel@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Carilion Clinic Orthopaedic Surgery
      • Contact: Linsen T Samuel, MD; Phone Number: 540-521-1474; Email: ltsamuel@carilionclinic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Group 1: In-person therapy; Standard of care, in-person therapy with a Certified Hand Therapist (CHT)
EXPERIMENTAL: Group 2: Home therapy program; Participants will be sent video links to three therapy videos demonstrating postoperative recovery exercises, starting 4 weeks after surgery.	Other: Video assisted home therapy; Subjects will follow along with prerecorded therapy videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.	Improvement in PROMIS upper extremity score from baseline. PROMIS scores are translated into t-scores and range from 0 (worst possible function) to 100 (best possible function). Positive improvement values indicate improvement in function. Negative values indicate a decline in function.	Change from baseline to Day 90 after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.	Improvement in PROMIS upper extremity score from baseline. PROMIS scores are translated into t-scores and range from 0 (worst possible function) to 100 (best possible function). Positive improvement values indicate improvement in function. Negative values indicate a decline in function.	Change from baseline to Day 365 after surgery.
Pain interference, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 1.0 Pain Interference 6a.	Difference in PROMIS pain interference score from baseline. PROMIS scores are translated into t-scores and range from 0 (minimum pain interference) to 100 (maximum pain interference). Negative differences from baseline indicate improvement in pain interference. Positive differences from baseline indicate worsening of pain interference.	Change from baseline to Day 90 after surgery.
Pain interference, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 1.0 Pain Interference 6a.	Difference in PROMIS pain interference score from baseline. PROMIS scores are translated into t-scores and range from 0 (minimum pain interference) to 100 (maximum pain interference). Negative differences from baseline indicate improvement in pain interference. Positive differences from baseline indicate worsening of pain interference.	Change from baseline to Day 365 after surgery.
Grip strength	Improvement in grip strength from baseline in operative hand. Measured in pounds force with a dynamometer. A positive change indicates gain of strength.	Change from baseline to Day 90 after surgery.
Key pinch strength	Improvement in key pinch strength from baseline in operative hand. Measured in pounds force with a dynamometer. A positive change indicates gain of strength.	Change from baseline to Day 90 after surgery.
3-finger pinch strength	Improvement in 3-finger pinch strength from baseline in operative hand. Measured in pounds force with a dynamometer. A positive change indicates gain of strength.	Change from baseline to Day 90 after surgery.
Thumb radial abduction	Improvement in thumb radial abduction from baseline in operative thumb. Measured in degrees with a goniometer. A positive change indicates gain of motion.	Change from baseline to Day 90 after surgery.
Thumb palmer abduction	Improvement in thumb palmer abduction from baseline in operative thumb. Measured in degrees with a goniometer. A positive change indicates gain of motion.	Change from baseline to Day 90 after surgery.

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Peter J Apel, MD, PhD, Carilion Clinic Department of Orthopaedics / Virginia Tech Carilion School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 9, 2021
• Primary Completion (ANTICIPATED): September 14, 2023
• Study Completion (ANTICIPATED): June 14, 2024

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (ACTUAL): November 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: hand surgery; video assisted therapy; CMC arthroplasty; carpometacarpal arthroplasty; thumb surgery; home therapy; self directed therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 20-865

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