Back to resultsDigital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
Primary Purpose
Knee Injuries, Knee Osteoarthritis, Patellofemoral Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limber Digital Application
Physical therapy Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring knee pain, knee osteoarthritis, patellofemoral syndrome, physical therapy, digital health
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital Home Exercise Program
Physical therapy
Arm Description
Limber Digital Application Device (3 x a week for 8 weeks)
Therapy prescription 2 x a week for 8 weeks (specified by physician)
Outcomes
Primary Outcome Measures
PROMIS Pain Score
Pain is measured by 0-100. 0 = no pain and 100 = very high pain
PROMIS Physical Function CAT
Function is measured by 0-100. 0= no function and 100 = high function
Secondary Outcome Measures
Subject Satisfaction Questions
Satisfaction questions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04323267
Brief Title
Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
Official Title
Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Knee Osteoarthritis, Patellofemoral Syndrome
Keywords
knee pain, knee osteoarthritis, patellofemoral syndrome, physical therapy, digital health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital Home Exercise Program
Arm Type
Experimental
Arm Description
Limber Digital Application Device (3 x a week for 8 weeks)
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
Therapy prescription 2 x a week for 8 weeks (specified by physician)
Intervention Type
Device
Intervention Name(s)
Limber Digital Application
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy Therapy
Intervention Description
Therapy prescription 2 x a week for 8 weeks (specified by physician)
Primary Outcome Measure Information:
Title
PROMIS Pain Score
Description
Pain is measured by 0-100. 0 = no pain and 100 = very high pain
Time Frame
8 weeks
Title
PROMIS Physical Function CAT
Description
Function is measured by 0-100. 0= no function and 100 = high function
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Subject Satisfaction Questions
Description
Satisfaction questions
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Sellon, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
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