An interventional study of Mobile Application in Osteoarthritis of Knee and Osteoarthritis Of Hip, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by University of Vermont · Not applicable, Interventional, and Treatment
Among 796 studies in Osteoarthritis, Knee with a site in United States — 110 open to participants now, 153 under way, 15 of them phase 3. Osteoarthritis, Knee · United States.
Among the 796 studies in Osteoarthritis, Knee with a site in United States, this one is the 375th largest by enrollment of the 691 interventional ones that give a count, is one of 55 that started in 2018, is one of 376 with no phase, and was the 388th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →110 of the 796 studies in Osteoarthritis, Knee with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Pfizer · Sites in United States, Canada
Margaret L Gourlay, MD, MPH · Sites in United States
VA Office of Research and Development · Sites in United States
Benedict Alter · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 50 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
796 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 60 · Phase 2 146 · Phase 3 89 · Phase 4 59
First in 1977; this study’s year is marked. 55 started in 2018.
This study's enrollment of 60 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 72 across the 691 interventional studies, 100 across the 101 observational. Of the 565 that completed or were terminated, 247 (44%) have results posted.
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265 of 796 have an industry lead sponsor. The 10 most frequent:
University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
University of Vermont has 1 study filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
53 of the studies in Osteoarthritis, Knee with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07226258Phase 3Saol Therapeutics IncPhase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain | 2026-11-30 |
| NCT07219771Phase 3Doron Therapeutics Inc.A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients (MOTION-P) | 2027-06-30 |
| NCT06917404Phase 3Paradigm Biopharmaceuticals Ltd.A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain. | 2027-07 |
| NCT04368806Phase 3Nature Cell Co. Ltd.A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis | 2027-08-06 |
| NCT07151417Phase 3Walter Reed National Military Medical CenterUse of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery. | 2027-08-31 |
Among the 796 studies in Osteoarthritis, Knee with a site in United States, from their registry updates:
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Osteoarthritis is the leading cause of disability in the U.S, particularly in older adults. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but adherence to prescribed exercise is generally low. Technology such as mobile applications (apps) for smartphones and tablets offers the potential to support exercise adherence through evidence-based components and enhanced communication between physical therapists and patients. The investigators aim to test mobile app-supported physical therapy exercise prescription compared to standard care. The investigators propose to use a two-arm randomized control trial with subjects in the intervention receiving mobile app-supported physical therapy exercise prescription and the control group receiving usual care physical therapy exercise prescription (paper handouts and verbal instruction). No known studies have assessed the impact of technological integration on adherence with PT exercises for OA. Current approaches such as therapist drawn pictures, hand-written or print-ready instructions do not account for patient communication preferences or ability to translate drawings into physical action. Mobile technology offers a potential solution to patient-centered care but has not been evaluated. This study will provide valuable information on effectiveness and user perspectives to key stakeholders such as patients, health care administrators, physical therapists and app designers.
Osteoarthritis (OA) is the leading cause of disability in the U.S. The rate of activity limitation due to OA is progressing faster than expected while prevalence is projected to increase as a result of the obesity epidemic and population aging, making it a major public health problem. Exercise is an evidence-based treatment option that improves pain and disability outcomes in adults with osteoarthritis, but previous research has shown that adherence to prescribed exercise is low. Referral to physical therapy is common for people with OA with the standard of care including exercise prescription through paper handouts with brief instruction and static pictures. Such approaches do not incorporate known determinants of behavior change related to exercise adherence.
Recent technology products such as mobile applications (apps) for phones and tablets offer the potential to enhance communication between physical therapists and patients. The investigators aim to test a pragmatic intervention focused on supporting people with osteoarthritis to remain engaged with an exercise program. The specific aims of the project are to:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The mobile app group will receive physical therapy as determined by the physical therapist and agree to receive the home exercise prescription using a mobile app on their phone or personal tablet
Device: Mobile Application
The control group will receive physical therapy as determined by the physical therapist based on clinical practice guidelines and will receive the home exercise program in the traditional way through paper exercise handouts
Participants will receive usual care physical therapy guided by Clinical Practice Guidelines and based on individual symptoms and need over 7 in-person visits. Measures will be collected by the physical therapist related to leg strength, balance, fitness, and mobility as part of the usual care physical therapy evaluation and follow-up. The treating physical therapist will negotiate the physical therapy intervention based on patient preferences and goals and assessment findings. Using clinical practice guidelines, the intervention for the research participants is expected to address deficits in strength, mobility, balance, and cardiovascular endurance. Exercise prescription will be provided using the Wellpepper physical therapy exercise prescription mobile app.
Exercise adherence
Mean weekly exercise frequency over 6 and 12 weeks:0-21 with higher scores indicating more adherence.
Time frame: 0, 6, and 12 weeks
ShortMAC Physical Function Patient Reported Outcome MeasureRO
12-item assessment of pain and function in people with osteoarthritis: 0-100 scale with higher scores for higher function and less pain
Time frame: 0, 6 and 12 weeks
2 minute walk test
Functional exercise capacity: Score is in meters/feet with higher distances indicating better exercise capacity
Time frame: 0, 6 and 12 weeks
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Time frame: 0, 6 and 12 weeks
Timed Up and Go (TUG) + Dual Task
Measure of physical function: Score is in seconds with higher scores indicating worse physical function
Time frame: 0, 6 and 12 weeks
Dynamic Balance: Four square balance test
Test of dynamic balance: Score is in seconds with lower scores indicating better dynamic balance
Time frame: 0, 6 and 12 weeks
Self-efficacy for exercise (SEE) Scale
Self-Efficacy for Exercise Scale: Score range 0-90 with higher score indicating higher self-efficacy for exercise
Time frame: 0, 6, and 12 weeks
Ran from Jan 2018 to primary completion in Jul 2019, 18 months.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 18 months is close to that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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