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Completed

NCT Number: NCT04323267

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

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.

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Key information

Conditions

Knee Injuries Arthritis Joint Diseases Knee Osteoarthritis Leg Injuries Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Patellofemoral Pain Syndrome Patellofemoral Syndrome Rheumatic Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Limber Digital Application

Device

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.

Physical therapy Therapy

Behavioral

Therapy prescription 2 x a week for 8 weeks (specified by physician)

Primary outcomes

  1. PROMIS Pain Score

    Time frame: 8 weeks

    Pain is measured by 0-100. 0 = no pain and 100 = very high pain

  2. PROMIS Physical Function CAT

    Time frame: 8 weeks

    Function is measured by 0-100. 0= no function and 100 = high function

Secondary outcomes

  1. Subject Satisfaction Questions

    Time frame: 8 weeks

    Satisfaction questions

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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