A Study to Evaluate the Effectiveness of Digital Home-Exercise Therapy for Patients with Non-surgical Knee Injuries
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-007031
- Minneapolis, Minnesota: 19-007031
NCT ID: NCT04323267
Sponsor Protocol Number: 19-007031
About this study
The purpose of this study is to test the feasibility of a Digital Home-Exercise Therapy Application (DETP) by conducting a randomized, controlled, non-inferiority study to compare the DETP to conventional physical therapy (PT).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jacob Sellon, M.D. |
Closed for enrollment |
|
Minneapolis, Minn.
Mayo Clinic principal investigator Jacob Sellon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available