OsteoarthritisNCT02270684
StepRite Evaluation
A study testing StepRite in people with Osteoarthritis, run by University of Southern California.
Trial summary
The purpose of this study is to compare the short-term changes in gait parameters and functional outcomes after total knee arthroplasty between those who use the StepRite device and those who follow a standard therapy program without the device. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- StepRite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral total knee arthroplasty performed under regional (spinal +/- epidural) or general anesthesia. Surgical approach via an anterior 4-6 inch incision and utilizing a medial parapatellar arthrotomy incision. Posterior stabilized total knee arthroplasty decision.
- Age 55-75 yr. old
- BMI <35
Who cannot join
- History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).
- Contralateral degenerative joint disease requiring a TKA.
- Pregnancy
About this study
Official title: Comparative Effectiveness of an Activity-Specific Monitoring Device (StepRite) on Short Term Outcomes in Adults After Total Knee Arthroplasty
The purpose of this study is to compare the short-term changes in gait parameters and functional outcomes after total knee arthroplasty between those who use the StepRite device and those who follow a standard therapy program without the device.
Read the detailed description
Total Knee Arthroplasty (TKA) is a procedure commonly used in severe degeneration of the knee joint due to osteoarthritis. With an increasing number of TKA's performed in a population that is aging during a time where the amount of healthcare dollars allotted to rehabilitation is declining, there is a need to develop remote monitoring of rehabilitation and to engage and optimize self-management of recovery.
Current management of TKA recovery is typically performed in the out-patient setting and is highly protocol driven. A typical case might be seen by the physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor progress (i.e. compliance with range of motion (ROM) and strengthening exercises). One recent study suggested that variation in patients' independent exercise and activity after arthroplasty surgery may contribute to variable functional gains.
Telerehabilitation is an emerging method of delivering healthcare. It is likely to become more prevalent as technology improves and funding for clinic appointments diminishes. Recent studies have shown that telerehabilitation can be as effective as conventional treatment, as is well tolerated by both patients and healthcare professionals.
The StepRite system developed by MedHab (http://www.medhab.com/) allows the physical therapist to monitor physical activity and exercise remotely, thereby reducing the need for frequent out-patient visits. A thin insole placed inside the shoe measures foot contact pressure and a small device attached to the shoe measures acceleration. This information is translated into quantitative feedback about exercise compliance and performance measures comparing the surgical side with the non-surgical side. Real time feedback during exercise and weight-bearing activities is provided to the patient, and a HIPAA secured user interface website also displays this information in an online dashboard for both physical therapists and the physician.
Given the potential for improving patient engagement with rehabilitation, this study proposes a treatment model which includes monitoring activity outside of the clinic using the StepRite device and using a combination of outpatient appointments and remote consultations with therapists.
Hypothesis
Patients who use the device post-surgery will demonstrate superior short-term improvements (i.e. 6 months post TKA) with respect to self-reported functional outcomes and gait parameters, compared to a control group who does not use the device.
- Conditions
- Osteoarthritis
- Being tested
- StepRite
- Keywords
- Total Knee Arthroplasty, Home monitoring
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StepRiteDevice
The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment Receives: Device: StepRite |
| Usual and customary care | No intervention | Participants in this arm will undergo usual care and will not be issued with the StepRite device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Osteoarthritis Outcome Score (KOOS)
The KOOS is a validated tool to measure pain and quality of life in patients after TKA
Measured: Baseline, 4, 10, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Recruitment and retention difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Powers, University of Southern California
- Investigators
- Christopher Powers, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270684
- Sponsor's protocol ID
- FP00002312
- Other IDs
- HS-13-00319
- Status last verified
- Apr 2017
- First submitted
- 17 Oct 2014
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of an Activity-Specific Monitoring Device (StepRite) on Short Term Outcomes in Adults After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02270684
- Acronym / sponsor ID
- FP00002312
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Home monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and retention difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the short-term changes in gait parameters and functional outcomes after total knee arthroplasty between those who use the StepRite device and those who follow a standard therapy program without the device.
Detailed description
Total Knee Arthroplasty (TKA) is a procedure commonly used in severe degeneration of the knee joint due to osteoarthritis. With an increasing number of TKA's performed in a population that is aging during a time where the amount of healthcare dollars allotted to rehabilitation is declining, there is a need to develop remote monitoring of rehabilitation and to engage and optimize self-management of recovery.
Current management of TKA recovery is typically performed in the out-patient setting and is highly protocol driven. A typical case might be seen by the physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor progress (i.e. compliance with range of motion (ROM) and strengthening exercises). One recent study suggested that variation in patients' independent exercise and activity after arthroplasty surgery may contribute to variable functional gains.
Telerehabilitation is an emerging method of delivering healthcare. It is likely to become more prevalent as technology improves and funding for clinic appointments diminishes. Recent studies have shown that telerehabilitation can be as effective as conventional treatment, as is well tolerated by both patients and healthcare professionals.
The StepRite system developed by MedHab (http://www.medhab.com/) allows the physical therapist to monitor physical activity and exercise remotely, thereby reducing the need for frequent out-patient visits. A thin insole placed inside the shoe measures foot contact pressure and a small device attached to the shoe measures acceleration. This information is translated into quantitative feedback about exercise compliance and performance measures comparing the surgical side with the non-surgical side. Real time feedback during exercise and weight-bearing activities is provided to the patient, and a HIPAA secured user interface website also displays this information in an online dashboard for both physical therapists and the physician.
Given the potential for improving patient engagement with rehabilitation, this study proposes a treatment model which includes monitoring activity outside of the clinic using the StepRite device and using a combination of outpatient appointments and remote consultations with therapists.
Hypothesis
Patients who use the device post-surgery will demonstrate superior short-term improvements (i.e. 6 months post TKA) with respect to self-reported functional outcomes and gait parameters, compared to a control group who does not use the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: StepRiteParticipants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment |
| Usual and customary care | No intervention | –Participants in this arm will undergo usual care and will not be issued with the StepRite device |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral total knee arthroplasty performed under regional (spinal +/- epidural) or general anesthesia. Surgical approach via an anterior 4-6 inch incision and utilizing a medial parapatellar arthrotomy incision. Posterior stabilized total knee arthroplasty decision.
- Age 55-75 yr. old
- BMI <35
Key exclusion criteria (3 listed)
- History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).
- Contralateral degenerative joint disease requiring a TKA.
- Pregnancy
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 |
|---|---|---|
| StepRiteThe StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete | Device | Device |
Primary outcome
Knee Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 4, 10, 24 weeks
The KOOS is a validated tool to measure pain and quality of life in patients after TKA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher Powers, PhD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing StepRite in people with Osteoarthritis, run by University of Southern California.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knee Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 4, 10, 24 weeks). 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 11 May 2017.