Knee InjuriesNCT04323267
Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
A study testing Limber Digital Application and Physical therapy Therapy in people with Knee Injuries and Knee Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Injuries, Knee Osteoarthritis, Patellofemoral Syndrome
- What is being tested?
- Limber Digital Application and Physical therapy Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial
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.
- Conditions
- Knee Injuries, Knee Osteoarthritis, Patellofemoral Syndrome
- Being tested
- Limber Digital Application, Physical therapy Therapy
- Keywords
- knee pain, knee osteoarthritis, patellofemoral syndrome, physical therapy, digital health
- Medical subject headings
- Knee Injuries, Osteoarthritis, Knee, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limber Digital ApplicationDevice
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 TherapyBehavioural
Therapy prescription 2 x a week for 8 weeks (specified by physician)
| Study group | Role | What they receive |
|---|---|---|
| Digital Home Exercise Program | Experimental | Limber Digital Application Device (3 x a week for 8 weeks) Receives: Device: Limber Digital Application |
| Physical therapy | Active comparator | Therapy prescription 2 x a week for 8 weeks (specified by physician) Receives: Behavioral: Physical therapy Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Pain Score
Pain is measured by 0-100. 0 = no pain and 100 = very high pain
Measured: 8 weeks
PROMIS Physical Function CAT
Function is measured by 0-100. 0= no function and 100 = high function
Measured: 8 weeks
Secondary outcomes (1)
Subject Satisfaction Questions
Satisfaction questions
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jan 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob L. Sellon, M.D., Mayo Clinic
- Investigators
- Jacob Sellon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323267
- Sponsor's protocol ID
- 19-007031
- Status last verified
- May 2020
- First submitted
- 23 Mar 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04323267
- Acronym / sponsor ID
- 19-007031
- Conditions
- Knee Injuries, Knee Osteoarthritis, Patellofemoral Syndrome
- Keywords
- knee pain, knee osteoarthritis, patellofemoral syndrome, physical therapy, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Home Exercise Program | Experimental | Device: Limber Digital ApplicationLimber Digital Application Device (3 x a week for 8 weeks) |
| Physical therapy | Active comparator | Behavioral: Physical therapy TherapyTherapy prescription 2 x a week for 8 weeks (specified by physician) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limber Digital ApplicationA 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. | Device | Digital Home Exercise Program |
| Physical therapy TherapyTherapy prescription 2 x a week for 8 weeks (specified by physician) | Behavioural | Physical therapy |
Primary outcome
PROMIS Pain Score
Time frame: 8 weeks
Pain is measured by 0-100. 0 = no pain and 100 = very high pain
PROMIS Physical Function CAT
Time frame: 8 weeks
Function is measured by 0-100. 0= no function and 100 = high function
1 secondary outcome
Subject Satisfaction Questions
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Sellon, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limber Digital Application and Physical therapy Therapy in people with Knee Injuries and Knee Osteoarthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pain Score (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.