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

Not Applicable

Completed

• Conditions: Knee Injuries; Knee Osteoarthritis; Patellofemoral Syndrome
• Interventions: Behavioral: Physical therapy Therapy; Device: Limber Digital Application

• Registration Number: NCT04323267
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Status Verified: 2020-05
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical therapy	Physical therapy Therapy	Therapy prescription 2 x a week for 8 weeks (specified by physician)
Digital Home Exercise Program	Limber Digital Application	Limber Digital Application Device (3 x a week for 8 weeks)

Primary Outcome Measures

Name	Time	Method
PROMIS Physical Function CAT	8 weeks	Function is measured by 0-100. 0= no function and 100 = high function
PROMIS Pain Score	8 weeks	Pain is measured by 0-100. 0 = no pain and 100 = very high pain

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction Questions	8 weeks	Satisfaction questions

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States