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

220 Participants Needed

Trial Summary

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 data supports the idea that Physical Therapy vs Remote Exercise for Osteoarthritis is an effective treatment?

The available research shows that virtual physical therapy, or remote exercise, is as effective as traditional face-to-face physical therapy for treating musculoskeletal disorders, which include osteoarthritis. Studies highlight that telehealth visits lead to high patient and provider satisfaction and offer strong positive effects on clinical outcomes. Additionally, remote exercise therapy provides increased intensity and effective management, making it a promising option for patients with osteoarthritis. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for osteoarthritis?

Research shows that virtual physical therapy is as effective as traditional face-to-face therapy for various musculoskeletal issues, and remote rehabilitation can lead to positive outcomes after surgery. This suggests that remote exercise therapy could be a promising option for managing osteoarthritis. ^{1 2 3 4 5}

Is remote exercise therapy safe for humans?

Remote exercise therapy, like telerehabilitation, is generally considered safe when proper measures are taken, such as monitoring by a therapist, to prevent adverse events during exercise sessions. ^{1 5 6 7 8}

What safety data exists for physical therapy and remote exercise for osteoarthritis?

Safety data for remote exercise therapy, including telerehabilitation, is scattered across various studies. Measures to ensure safety during telerehabilitation include telephone monitoring and therapist-led sessions. Concerns about safety arise when patients exercise without direct supervision, either in-person or remotely. While telerehabilitation offers benefits like increased access and cost savings, it requires patient involvement and adherence to be effective. Overall, safety measures are in place, but the effectiveness and safety of remote exercise therapy depend on proper implementation and patient engagement. ^{1 5 6 7 8}

Is Technology-implemented exercise therapy a promising treatment for osteoarthritis?

Yes, Technology-implemented exercise therapy is promising for osteoarthritis. It allows patients to receive high-quality care remotely, with high satisfaction from both patients and providers. It is as effective as traditional face-to-face physical therapy for musculoskeletal issues and offers scalable access to rehabilitation. This approach also provides real-time feedback to help patients exercise correctly at home. ^{1 3 4 5 9}

How does the treatment of physical therapy vs remote exercise for osteoarthritis differ from other treatments?

This treatment is unique because it uses technology to deliver exercise therapy remotely, allowing patients to receive guidance and feedback from physical therapists through digital platforms, which can be more accessible and convenient compared to traditional in-person physical therapy sessions. ^{1 3 4 5 9}

What is the purpose of this trial?

The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.

Research Team

Laura Tabacof

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Telehealth Physical Therapy in Musculoskeletal Practice. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Telemedicine for Musculoskeletal Rehabilitation and Orthopedic Postoperative Rehabilitation. [2021]

5. United States 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. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain. [2021]

9. United States 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. [2023]