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

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Mayo Clinic

Status

Completed

Conditions

Knee Injuries
Patellofemoral Syndrome
Knee Osteoarthritis

Treatments

Device: Limber Digital Application
Behavioral: Physical therapy Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04323267
19-007031

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Digital Home Exercise Program
Experimental group
Description:
Limber Digital Application Device (3 x a week for 8 weeks)
Treatment:
Device: Limber Digital Application
Physical therapy
Active Comparator group
Description:
Therapy prescription 2 x a week for 8 weeks (specified by physician)
Treatment:
Behavioral: Physical therapy Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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