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NCT04625244 | RECRUITING | Thumb Osteoarthritis


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

Carilion Clinic

Information provided by (Responsible Party):

Peter J Apel

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.

Condition or disease

Thumb Osteoarthritis

Intervention/treatment

Video assisted home therapy

Phase

NA

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
Estimated Enrollment : 134 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: A Noninferiority Study
Actual Study Start Date : 2021-06-09
Estimated Primary Completion Date : 2023-09-14
Estimated Study Completion Date : 2024-06-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

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

Location Details

NCT04625244


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Locations


RECRUITING

United States, Virginia

Carilion Clinic Orthopaedic Surgery

Roanoke, Virginia, United States, 24014

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