Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries

Study Overview
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Brief Summary
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Knee pain is one of the most prevalent musculoskeletal disorders in the United States. Conservative treatments generally consist of pharmacological agents and physical therapy. Unfortunately, such conservative care is often mismanaged, and little data is collected on clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile application (DETP) to guide an at-home exercise therapy program for non-operative knee pain. The purpose of this study is conducting a single-blind randomized, controlled, superiority study to compare the DETP to conventional physical therapy (PT). The investigators will seek to determine improvement in pain and function in PROMIS measures as the primary outcome. The investigators will also evaluate satisfaction with the application as a secondary outcome.

Official Title
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Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial

Conditions
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Knee Injuries, Knee Osteoarthritis, Patellofemoral Syndrome

Intervention / Treatment
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* Device: Limber Digital Application
* Behavioral: Physical therapy Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75, inclusive. Diagnosis of knee injury. For participants enrolled from the Mayo healthcare system database, knee injury identified from electronic medical records. Pain Numerical Rating Scale score of 4 or greater on a 0-10 scale (0 = no pain, 10 = pain). Participants must be diagnosed with a knee injury and the next step of care is either a home exercise program or external physical therapy ordered at the academic center. Prescribed external physical therapy (i.e., therapy not completed at Mayo Clinic in Rochester/Minneapolis). Exclusion Criteria: No access to android or iPhone smartphone BMI greater than or equal to 35 Previously completed series of physical therapy visits for knee injury within the past 12 months for the same injury (received one introduction PT session as seen in executive program will not be considered an exclusion). Recommended by a physician for consideration of total knee replacement. Diagnosis of rheumatoid arthritis, fibromyalgia, gout in the knee, or other systemic rheumatic disease. Hospitalization for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 12 months. Total joint replacement knee surgery, bucket-handle meniscus tear, ACL tear, or other knee surgery in the past 12 months. Unable to speak English. Active diagnosis of psychosis. Fall history deemed by a physician to impose risk for potential injury with participation in a home-based exercise program. Severely impaired hearing or speech.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Home Exercise Program<br>Limber Digital Application Device (3 x a week for 8 weeks) | Device: Limber Digital Application<br>* A mobile application was recently developed to address these needs. The application provides evidence-based, symptom specific home-exercise video programs for MSK conditions, as well as clinically-validated outcome measures for tracking progress.<br>|
| Active Comparator: Physical therapy<br>Therapy prescription 2 x a week for 8 weeks (specified by physician) | Behavioral: Physical therapy Therapy<br>* Therapy prescription 2 x a week for 8 weeks (specified by physician)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain Score | Pain is measured by 0-100. 0 = no pain and 100 = very high pain | 8 weeks | 
| PROMIS Physical Function CAT | Function is measured by 0-100. 0= no function and 100 = high function | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction Questions | Satisfaction questions | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee pain, knee osteoarthritis, patellofemoral syndrome, physical therapy, digital health