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

NCT04625244 | Completed

• 1 other identifier: 20-865
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Thumb Osteoarthritis

Keywords

video assisted therapy; CMC arthroplasty; carpometacarpal arthroplasty; thumb surgery; hand surgery; home therapy; self directed therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.

  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.

  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.

  Change from baseline to Day 365 after surgery.

• Grip strength

  Change from baseline to Day 90 after surgery.

• Key pinch strength

  Change from baseline to Day 90 after surgery.

Study Arms (2)

Group 1: In-person therapy

NO INTERVENTION

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

Group 2: Home therapy program

EXPERIMENTAL

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

Other: Video assisted home therapy

Interventions

Video assisted home therapy OTHER

Subjects will follow along with prerecorded therapy videos.

Group 2: Home therapy program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic Orthopaedic Surgery

Roanoke, Virginia, 24014, United States

Location

Related Publications (3)

• 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.

  PMID: 29950288 BACKGROUND

• 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.

  PMID: 30702438 BACKGROUND

• 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.

  PMID: 31625400 BACKGROUND

Study Officials

• Peter J Apel, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Hand and Upper Extremity Surgeon

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: June 9, 2021
• Primary Completion: September 14, 2023
• Study Completion: April 14, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)