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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323267
• Other study ID #: 19-007031
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: May 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Injuries
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Patellofemoral Pain Syndrome
• Patellofemoral Syndrome
• Wounds and Injuries

Intervention

Device:
• Limber Digital Application
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.

Behavioral:
• Physical therapy Therapy
Therapy prescription 2 x a week for 8 weeks (specified by physician)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Pain Score	Pain is measured by 0-100. 0 = no pain and 100 = very high pain	8 weeks
Primary	PROMIS Physical Function CAT	Function is measured by 0-100. 0= no function and 100 = high function	8 weeks
Secondary	Subject Satisfaction Questions	Satisfaction questions	8 weeks

External Links

•   Mayo Clinic Clinical Trials