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

NCT ID: NCT04323267

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-05-15

Brief Summary

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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

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Conditions

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Knee Injuries Knee Osteoarthritis Patellofemoral Syndrome

Keywords

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knee pain knee osteoarthritis patellofemoral syndrome physical therapy digital health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Digital Home Exercise Program

Limber Digital Application Device (3 x a week for 8 weeks)

Group Type EXPERIMENTAL

Limber Digital Application

Intervention Type DEVICE

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.

Physical therapy

Therapy prescription 2 x a week for 8 weeks (specified by physician)

Group Type ACTIVE_COMPARATOR

Physical therapy Therapy

Intervention Type BEHAVIORAL

Therapy prescription 2 x a week for 8 weeks (specified by physician)

Interventions

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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.

Intervention Type DEVICE

Physical therapy Therapy

Therapy prescription 2 x a week for 8 weeks (specified by physician)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jacob L. Sellon, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacob Sellon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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19-007031

Identifier Type: -

Identifier Source: org_study_id