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

Primary Purpose

Thumb Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video assisted home therapy
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring video assisted therapy, CMC arthroplasty, carpometacarpal arthroplasty, thumb surgery, hand surgery, home therapy, self directed therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carilion Clinic Orthopaedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1: In-person therapy

Group 2: Home therapy program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 6, 2020
Last Updated
February 7, 2023
Sponsor
Carilion Clinic
Collaborators
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT04625244
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
June 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
Collaborators
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
Keywords
video assisted therapy, CMC arthroplasty, carpometacarpal arthroplasty, thumb surgery, hand surgery, home therapy, self directed therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: In-person therapy
Arm Type
No Intervention
Arm Description
Standard of care, in-person therapy with a Certified Hand Therapist (CHT)
Arm Title
Group 2: Home therapy program
Arm Type
Experimental
Arm Description
Participants will be sent video links to three therapy videos demonstrating postoperative recovery exercises, starting 4 weeks after surgery.
Intervention Type
Other
Intervention Name(s)
Video assisted home therapy
Intervention Description
Subjects will follow along with prerecorded therapy videos.
Primary Outcome Measure Information:
Title
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.
Description
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.
Time Frame
Change from baseline to Day 90 after surgery.
Secondary Outcome Measure Information:
Title
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.
Description
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.
Time Frame
Change from baseline to Day 365 after surgery.
Title
Pain interference, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 1.0 Pain Interference 6a.
Description
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.
Time Frame
Change from baseline to Day 90 after surgery.
Title
Pain interference, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 1.0 Pain Interference 6a.
Description
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.
Time Frame
Change from baseline to Day 365 after surgery.
Title
Grip strength
Description
Improvement in grip strength from baseline in operative hand. Measured in pounds force with a dynamometer. A positive change indicates gain of strength.
Time Frame
Change from baseline to Day 90 after surgery.
Title
Key pinch strength
Description
Improvement in key pinch strength from baseline in operative hand. Measured in pounds force with a dynamometer. A positive change indicates gain of strength.
Time Frame
Change from baseline to Day 90 after surgery.
Title
3-finger pinch strength
Description
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.
Time Frame
Change from baseline to Day 90 after surgery.
Title
Thumb radial abduction
Description
Improvement in thumb radial abduction from baseline in operative thumb. Measured in degrees with a goniometer. A positive change indicates gain of motion.
Time Frame
Change from baseline to Day 90 after surgery.
Title
Thumb palmer abduction
Description
Improvement in thumb palmer abduction from baseline in operative thumb. Measured in degrees with a goniometer. A positive change indicates gain of motion.
Time Frame
Change from baseline to Day 90 after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linsen T Samuel, MD
Phone
540-521-1474
Email
ltsamuel@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Apel, MD, PhD
Organizational Affiliation
Carilion Clinic Department of Orthopaedics / Virginia Tech Carilion School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic Orthopaedic Surgery
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linsen T Samuel, MD
Phone
540-521-1474
Email
ltsamuel@carilionclinic.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29950288
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.
Results Reference
background
PubMed Identifier
30702438
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.
Results Reference
background
PubMed Identifier
31625400
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.
Results Reference
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Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: A Noninferiority Study

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