Physical Therapy vs Remote Exercise for Osteoarthritis

Overseen By Sophia Salazar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cognitive impairment, Knee arthroplasty, Inflammatory arthritis, Neuropathies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two exercise therapies to determine which is more effective for people with knee osteoarthritis (OA). One group will perform exercises at home using an app and have virtual check-ins with a physical therapist, known as technology-implemented exercise therapy. The other group will attend traditional in-person physical therapy sessions. The goal is to determine if home exercise can be as effective as in-person therapy. This trial may suit those in the CT/NY/NJ area who have experienced chronic knee pain for over three months and have access to an internet-enabled device. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance exercise therapy options for knee OA.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exercise therapies are safe for osteoarthritis?

Research has shown that exercise plans using apps are generally safe for people with osteoarthritis. One study found no difference in side effects between those using an exercise app and those who did not, indicating that home exercises with an app are as safe as traditional methods.

Another study found that digital exercise therapy can help reduce pain and improve movement, supporting the idea that this therapy is a safe and effective option.

In short, using technology to exercise at home is well-tolerated by people with osteoarthritis. It provides a safe way to enjoy the benefits of physical therapy without visiting a clinic. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for osteoarthritis because they introduce innovative approaches to exercise therapy. The technology-implemented exercise therapy allows patients to receive personalized exercise plans at home, overseen remotely by a physical therapist through smart devices. This offers greater flexibility and accessibility compared to traditional physical therapy, which requires in-person visits. Traditional physical therapy remains an essential option, providing hands-on assessments and tailored guidance. The trial aims to determine if the convenience and personalization of remote therapy can match or exceed the effectiveness of standard in-person care.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare Technology-implemented exercise therapy with Traditional Physical Therapy for osteoarthritis. Research has shown that digital exercise therapy, one of the treatments in this trial, can significantly reduce pain and improve movement in people with osteoarthritis (OA). Studies have found that exercises performed through digital platforms can enhance quality of life by easing knee pain and increasing activity levels. Programs supported by telehealth also improve physical function and teach pain management. Traditional physical therapy, the other treatment option in this trial, is a proven method for managing OA, known for alleviating pain and enhancing mobility. Both treatments in this trial aim to improve joint function and reduce discomfort, offering promising options for those with knee OA. ^{2 6 7 8 9}

Who Is on the Research Team?

Laura Tabacof

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in CT/NY/NJ with knee pain from osteoarthritis, who've had this pain for more than 3 months and have an average pain score of at least 4 out of 11. They must have internet access and be in the early to moderate stages of OA. People with cognitive impairments, recent surgeries or falls, severe heart disease, bleeding disorders, or those already doing physical therapy can't join.

Inclusion Criteria

I have painful osteoarthritis according to official health guidelines.

My knee arthritis is mild to moderate.

Living in the tristate area - CT/NY/NJ

Exclusion Criteria

I have no history of severe arthritis, neuropathies, recent surgery, falls, or conditions that increase fracture risk.

I have injured my knee in the last 3 months.

Prior documented history of cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week at-home exercise program, 3 times per week with SimpleTherapy, or traditional physical therapy sessions.

6 weeks

Remote visits for SimpleTherapy group; In-person visits twice a week for traditional PT group

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including PGI-C, BPI-SF, and other measures.

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Technology-implemented exercise therapy
• Traditional Physical Therapy

Trial Overview The study compares two ways to treat knee pain due to osteoarthritis: traditional physical therapy versus a home-based exercise program called SimpleTherapy. Participants will follow their assigned treatment three times a week for six weeks to see if the remote exercise is as effective as regular physical therapy.

How Is the Trial Designed?

Group I: Technology-implemented exercise therapy Experimental Treatment 1 Intervention

Therapy plans performed at home overseen by a remote physical therapist via SimpleTherapy. Allocation to this group will require using smart devices or a computer/laptop to receive care. Remote visits with a PT typically last 45min long and home exercises suggested by the app are self-paced.

Group II: Traditional Physical Therapy Active Control 1 Intervention

Participants will be prescribed an exercise plan by a physical therapist as normally would occur as part of standards of care outside the context of a research study. In-person assessments and at-home exercise suggestions will be decided by the physical therapist. Duration of PT appointments is typically 45 minutes long two times per week and are supplemented by PT recommended self-paced at-home exercises.

Technology-implemented exercise therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Digital Physical Therapy for:

• Knee pain due to osteoarthritis
• Rehabilitation after surgery
• Musculoskeletal disorders

Approved in European Union as Telehealth Exercise Therapy for:

• Chronic pain management
• Physical rehabilitation
• Neurological disorders

Approved in Canada as Virtual Rehabilitation for:

• Orthopedic rehabilitation
• Cardiovascular rehabilitation
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

A scoping review of 107 studies involving 3991 participants with stroke found that safety measures during asynchronous telerehabilitation exercises are rarely reported, with only 10 studies detailing such measures.

Common safety strategies included assessing exercise locations, using seated positions, and implementing live warning systems to prevent risky exercises, highlighting the need for more comprehensive reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. Gutierrez-Arias, R., González-Mondaca, C., Marinkovic-Riffo, V., et al.[2023]

This study will evaluate the effectiveness of a remote physical therapist intervention over 12 weeks in increasing physical activity among 100 adults with knee osteoarthritis, comparing it to existing web-based resources.

The primary outcome measured will be moderate-to-vigorous physical activity, with the goal of demonstrating that telehealth can effectively enhance physical activity levels and manage knee OA symptoms through structured exercise guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial. Jakiela, JT., Voinier, D., Hinman, RS., et al.[2023]

Telecommunication technology offers significant potential to improve access to medical services for patients in underserved areas, particularly in cardiopulmonary physical therapy, where its use is currently limited.

Barriers to the adoption of telehealth in physical therapy include unfamiliarity with technology and misconceptions about costs, highlighting the need for better education and clarity in terminology related to telehealth practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of telehealth and its application to cardiopulmonary physical therapy. Shaw, DK.[2021]

The REWIRE platform for autonomous telerehabilitation demonstrated safety with no adverse events reported during a 12-week study involving 15 stroke patients, indicating it is a secure option for home-based rehabilitation.

Participants showed high compliance with the program, completing an average of 71% of scheduled sessions, and reported excellent acceptance of the system, suggesting it is both effective and well-received for improving balance and gait at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system. Held, JP., Ferrer, B., Mainetti, R., et al.[2022]

Telehealth physical therapy has significant potential to improve care in musculoskeletal practice, but its widespread use is currently hindered by payment and regulatory challenges.

There is a need for further examination of the evidence supporting telehealth in musculoskeletal treatment and exploration of future opportunities to enhance its implementation in the digital age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Physical Therapy in Musculoskeletal Practice. Lee, AC., Davenport, TE., Randall, K.[2019]

A survey of 330 individuals with hip and/or knee osteoarthritis revealed that most participants (over 50%) had positive perceptions of tele-rehabilitation, particularly valuing its time-saving benefits and ease of use.

Despite the overall positive feedback, there were concerns about the effectiveness of remote exercise delivery and the lack of physical contact with therapists, indicating a need for further exploration of these aspects in tele-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer Perceptions of and Willingness to Use Remotely Delivered Service Models For Exercise Management of Knee and Hip Osteoarthritis: A Cross-Sectional Survey. Lawford, BJ., Bennell, KL., Hinman, RS.[2018]

Physical therapists believe that web-based telerehabilitation can effectively treat chronic low back pain (CLBP) by allowing for greater patient engagement and follow-up, but success depends on patients actively participating in their treatment.

While new technologies can expand access to therapy and reduce healthcare costs, there are challenges in ensuring that exercise programs are tailored to individual patient preferences and that patients understand the correct techniques for long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain. Martínez de la Cal, J., Fernández-Sánchez, M., Matarán-Peñarrocha, GA., et al.[2021]

Telehealth visits provide high-quality care with strong patient and provider satisfaction, showing that virtual physical therapy is just as effective as traditional in-person therapy for musculoskeletal disorders.

Postoperative telerehabilitation significantly improves clinical outcomes and offers increased intensity in rehabilitation programs, making it a promising option for patient recovery, especially following the COVID-19 pandemic which has enhanced telehealth reimbursement and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine for Musculoskeletal Rehabilitation and Orthopedic Postoperative Rehabilitation. Phuphanich, ME., Sinha, KR., Truong, M., et al.[2021]

The Motion Coach app provides real-time audiovisual feedback on exercise execution for patients with osteoarthritis and shows interrater agreement with physiotherapists that is comparable to evaluations made by two different physiotherapists, indicating its reliability.

In a study involving 24 participants, the Motion Coach app demonstrated noninferior performance in assessing exercise form, suggesting it can effectively support rehabilitation for musculoskeletal disorders without significant differences in accuracy across various age, gender, or BMI subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study. Biebl, JT., Rykala, M., Strobel, M., et al.[2021]

Citations

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Effect of Digital Exercise Therapy on the Pain and Physical ... Digital exercise therapy can alleviate the pain and improve the physical function in patients with OA and can be used as an auxiliary means in the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1063458423009883

How effective are exercises delivered digitally (requiring ... The aim of this systematic review and meta-analysis is to describe the effect of digitally delivered exercise on pain, physical function and quality of life ( ...

3. jmir.org jmir.org/2024/1/e54876/

Telehealth-Supported Exercise or Physical Activity ... Telehealth-supported exercise or physical activity programs might reduce knee pain and improve physical activity, physical function, quality of life, self- ...

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Effect of the telemedicine-supported multicomponent exercise ... The aim of the study is to evaluate the effectiveness of multicomponent exercise therapy aimed at enhancing pain self-management for knee ...

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Rural Access to Physical Therapy for Osteoarthritis ... Data Sharing: Deidentified outcomes data at baseline and post-treatment ... To maximize safety when performing telerehabilitation exercises at home without a ...

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App-based exercise intervention versus supervised ... We aimed to determine whether the use of an exercise app was noninferior to supervised exercise therapy in patients with hip/knee osteoarthritis. Methods. In ...

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Usability and Reliability of a New Physical Therapy Tool Rehabilitation exercise conducted at home following injury improves clinical and functional outcomes. Optimum compliance with prescribed exercise regimens ...