Thumb OsteoarthritisNCT04625244
Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: a Noninferiority Study
A study testing Video assisted home therapy in people with Thumb Osteoarthritis, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Video assisted home therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 14 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Clinic Orthopaedic Surgery
Roanoke, Virginia, 24014
About this 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.
Read the 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
- Being tested
- Video assisted home therapy
- Keywords
- video assisted therapy, CMC arthroplasty, carpometacarpal arthroplasty, thumb surgery, hand surgery, home therapy, self directed therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video assisted home therapyOther
Subjects will follow along with prerecorded therapy videos.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Video assisted home therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to Day 90 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start9 Jun 2021
- Primary completion14 Sep 2023
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Peter J Apel, Carilion Clinic
- Investigators
- Peter J Apel, MD, PhD, Principal investigator, Carilion Clinic Department of Orthopaedics / Virginia Tech Carilion School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625244
- Sponsor's protocol ID
- 20-865
- Status last verified
- Apr 2024
- First submitted
- 6 Nov 2020
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29950288Hoogland 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.
PubMed 30702438Lee 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.
PubMed 31625400
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: a Noninferiority Study
- ClinicalTrials.gov ID
- NCT04625244
- Acronym / sponsor ID
- 20-865
- Conditions
- Thumb Osteoarthritis
- Keywords
- video assisted therapy, CMC arthroplasty, carpometacarpal arthroplasty, thumb surgery, hand surgery, home therapy, self directed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Video assisted home therapyParticipants will be sent video links to three therapy videos demonstrating postoperative recovery exercises, starting 4 weeks after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video assisted home therapySubjects will follow along with prerecorded therapy videos. | Other | Group 2: Home therapy program |
Primary outcome
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.
Time frame: Change from baseline to Day 90 after surgery.
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.
8 secondary outcomes
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to Day 365 after surgery.
Grip strength
Time frame: Change from baseline to Day 90 after surgery.
Key pinch strength
Time frame: Change from baseline to Day 90 after surgery.
3-finger pinch strength
Time frame: Change from baseline to Day 90 after surgery.
Thumb radial abduction
Time frame: Change from baseline to Day 90 after surgery.
Thumb palmer abduction
Time frame: Change from baseline to Day 90 after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 29950288Srikesavan 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.
- Background: PubMed 30702438Hoogland 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.
- Background: PubMed 31625400Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Apel, MD, PhD principal investigator
Carilion Clinic Department of Orthopaedics / Virginia Tech Carilion School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video assisted home therapy in people with Thumb Osteoarthritis, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity function, as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) v. 2.0 Upper Extremity assessment. (time frame: Change from baseline to Day 90 after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625244, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.