Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite
| Status: | Terminated |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 45 - 75 |
| Updated: | 11/10/2017 |
| Start Date: | October 21, 2016 |
| End Date: | November 2017 |
Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite - on Short Term Outcomes in Adults After Partial or Total Knee Arthroplasty
Partial or Total Knee Arthroplasty are procedures commonly used in severe degeneration of the
knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee
Arthroplasty 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 Partial or Total Knee Arthroplasty 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 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.
The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert
that collects functional data) will reduce cost and improve the efficacy of rehabilitation in
total knee arthroplasty patients
knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee
Arthroplasty 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 Partial or Total Knee Arthroplasty 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 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.
The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert
that collects functional data) will reduce cost and improve the efficacy of rehabilitation in
total knee arthroplasty patients
Significance of this study The significance of the proposed study includes the projected
benefit to the patients in terms of attaining clinical outcomes quicker and to the medical
system in terms of managing cost for the provision of services. Subjects are expected to
demonstrate improved compliance to patient tailored rehabilitation protocols which will lead
to more rapid attainment of clinical outcomes versus present traditional rehabilitation
methodologies. The expected level of, and rate of, attainment of clinical outcomes will
translate to an overall reduction of cost to the medical system by reducing the need to
engage in additional processes or the need to protract the time required to attain clinical
outcomes, where either or both in combination can increase rehabilitation expenditures.
Objectives To compare the efficacy of StepRite in a prescribed physical therapy program
verses traditional in-facility physical therapy program after partial or total knee
replacement surgery using validated survey tools to evaluate patient progress, including
patient self -reporting of progress and surgeon appraisal of patient performance
post-operatively.
To compare the overall cost of post-operative rehabilitation of patients involved in
traditionally employed regimens versus those using the StepRite device.
Hypothesis and specific aims The aim of this study is to evaluate whether improved clinical
outcomes as well as reduction in cost in provision of care can be better affected through the
use of the Steprite device as compared to the use of traditional rehabilitation modalities.
The Investigators will seek to reject the null hypotheses that 1) there is no difference
between clinical outcomes attained between patients using the Steprite device and those using
traditional rehabilitation modalities and that 2) there is no reduction in cost to the
medical system when patients use Steprite versus other conventional methods of
rehabilitation.
By rejecting the null hypothesis the investigators will accept the alternate hypothesis that,
through the use of the Steprite device, not only will patients achieve overall clinical
outcomes faster but there will be an associated decrease in cost burden to the medical system
and the differences observed will be statistically significant as compared to rehabilitation
of patients not using the Steprite device.
Patients who use the device post-surgery will demonstrate superior short-term improvements
(i.e. 3 months post surgery) with respect to self-reported functional outcomes and gait
parameters, compared to a control group not using the device. The patients will self-report
through the use of validated survey instruments including the KOOS survey (knee injury and
osteoarthritis outcome score), LEFS (lower extremity functional scale) and/or KSS (knee
society score), the latter of which includes a section for surgeon evaluation of patient
functionality post operatively.
Study Design and Methods This is a point of care clinical trial; a trial that functions to
integrate research within a clinical setting that has the ability to readily deliver either
modality of the proposal. This type of study design relies on provider referral of patients
to be approached for consent, after which randomization to one of two treatment groups is
facilitated; a control group of 15 patients participating in conventional rehabilitation
regimens and an experimental group of 15 patients who will participate in the same
rehabilitation regimen but facilitated through the use of Steprite. Importantly, care for
patients is delivered as part of current adopted standards utilizing outcome measurements,
the use of which and the interpretation of which is already built into care provided by the
clinical facility, thereby negating the need to develop additional outcome measures.
Recruitment of 30 patients will come from the investigators' normal patient population, among
patients who are scheduled for partial or total knee arthroplasty. As there is no change in
post op care for these patients from the investigators standard protocols other than
monitoring and enforcement of home protocols, the same therapists involved in investigators'
normal patient care will be involved with both arms of the study.
For this study, 30 patients represents a sample size deemed acceptable as a starting point.
There are no other published studies using Steprite in comparative design trials.
Determinations of sample size needed for this study, using 80% power and significance of
0.05, incorporate the use of a time frame in days or weeks for completion of the
rehabilitation protocols that would allow for the detection of clinically significant
differences between the group using Steprite and those using conventional therapies only.
Given that conventional therapies can include skilled nursing, home health and outpatient
visits and given that the need for each of these is highly variable dependent on the patient,
it is difficult to assign a time value for determinations of sample size.
With that, a sample size of 30 participants divided into two groups represents an initial
starting point, with the potential of incremental addition of more patients in order to
achieve significance between the two study groups.
Statistical significance will be evaluated utilizing a standard t-test for two group
comparison.
In preparation for the study, MedHab Inc. will at their expense train all involved
investigators and therapists in the fitting and use of the StepRite device. Medhab will also
train a lead therapist designated by the lead investigator to be in charge of overseeing and
monitoring, ensuring proper use of the device. There is no cost to the patient, hospital or
other funding entity for participation in this study. Medhab LLC will assume all costs
associated with the training, application, device and use of the StepRite product for the
full course of this study.
Subjects for this study will be recruited from the patient population seen by the
investigator's during the normal course of business. There will be no outside recruitment of
individuals or advertising as to the presence or use of the monitoring device to entice new
patient referral. Prospective candidates will be asked by the investigator at the time they
are designated surgical candidates. All documentation related to the study will be reviewed
with the patient by the lead physician or his designee who is appropriately trained in
discussing patient recruitment. Final decision and randomization to control or StepRite use
will be done as part of the preoperative checkup just prior to surgery where both operative
consent and study consent are discussed and signed.
Randomization:
Once a patient agrees to the study they would be sequentially randomized into whether or not
they receive StepRite. The patients will be randomized to every other eligible patient gets
the intervention. (ie: 1,3,5,7,9… will get StepRite ; 2,4,6,8 will not get StepRite) 15
Intervention subjects will be recruited and 15 control subjects will be recruited with an
extra 5 patients to account for attrition and withdrawals.
benefit to the patients in terms of attaining clinical outcomes quicker and to the medical
system in terms of managing cost for the provision of services. Subjects are expected to
demonstrate improved compliance to patient tailored rehabilitation protocols which will lead
to more rapid attainment of clinical outcomes versus present traditional rehabilitation
methodologies. The expected level of, and rate of, attainment of clinical outcomes will
translate to an overall reduction of cost to the medical system by reducing the need to
engage in additional processes or the need to protract the time required to attain clinical
outcomes, where either or both in combination can increase rehabilitation expenditures.
Objectives To compare the efficacy of StepRite in a prescribed physical therapy program
verses traditional in-facility physical therapy program after partial or total knee
replacement surgery using validated survey tools to evaluate patient progress, including
patient self -reporting of progress and surgeon appraisal of patient performance
post-operatively.
To compare the overall cost of post-operative rehabilitation of patients involved in
traditionally employed regimens versus those using the StepRite device.
Hypothesis and specific aims The aim of this study is to evaluate whether improved clinical
outcomes as well as reduction in cost in provision of care can be better affected through the
use of the Steprite device as compared to the use of traditional rehabilitation modalities.
The Investigators will seek to reject the null hypotheses that 1) there is no difference
between clinical outcomes attained between patients using the Steprite device and those using
traditional rehabilitation modalities and that 2) there is no reduction in cost to the
medical system when patients use Steprite versus other conventional methods of
rehabilitation.
By rejecting the null hypothesis the investigators will accept the alternate hypothesis that,
through the use of the Steprite device, not only will patients achieve overall clinical
outcomes faster but there will be an associated decrease in cost burden to the medical system
and the differences observed will be statistically significant as compared to rehabilitation
of patients not using the Steprite device.
Patients who use the device post-surgery will demonstrate superior short-term improvements
(i.e. 3 months post surgery) with respect to self-reported functional outcomes and gait
parameters, compared to a control group not using the device. The patients will self-report
through the use of validated survey instruments including the KOOS survey (knee injury and
osteoarthritis outcome score), LEFS (lower extremity functional scale) and/or KSS (knee
society score), the latter of which includes a section for surgeon evaluation of patient
functionality post operatively.
Study Design and Methods This is a point of care clinical trial; a trial that functions to
integrate research within a clinical setting that has the ability to readily deliver either
modality of the proposal. This type of study design relies on provider referral of patients
to be approached for consent, after which randomization to one of two treatment groups is
facilitated; a control group of 15 patients participating in conventional rehabilitation
regimens and an experimental group of 15 patients who will participate in the same
rehabilitation regimen but facilitated through the use of Steprite. Importantly, care for
patients is delivered as part of current adopted standards utilizing outcome measurements,
the use of which and the interpretation of which is already built into care provided by the
clinical facility, thereby negating the need to develop additional outcome measures.
Recruitment of 30 patients will come from the investigators' normal patient population, among
patients who are scheduled for partial or total knee arthroplasty. As there is no change in
post op care for these patients from the investigators standard protocols other than
monitoring and enforcement of home protocols, the same therapists involved in investigators'
normal patient care will be involved with both arms of the study.
For this study, 30 patients represents a sample size deemed acceptable as a starting point.
There are no other published studies using Steprite in comparative design trials.
Determinations of sample size needed for this study, using 80% power and significance of
0.05, incorporate the use of a time frame in days or weeks for completion of the
rehabilitation protocols that would allow for the detection of clinically significant
differences between the group using Steprite and those using conventional therapies only.
Given that conventional therapies can include skilled nursing, home health and outpatient
visits and given that the need for each of these is highly variable dependent on the patient,
it is difficult to assign a time value for determinations of sample size.
With that, a sample size of 30 participants divided into two groups represents an initial
starting point, with the potential of incremental addition of more patients in order to
achieve significance between the two study groups.
Statistical significance will be evaluated utilizing a standard t-test for two group
comparison.
In preparation for the study, MedHab Inc. will at their expense train all involved
investigators and therapists in the fitting and use of the StepRite device. Medhab will also
train a lead therapist designated by the lead investigator to be in charge of overseeing and
monitoring, ensuring proper use of the device. There is no cost to the patient, hospital or
other funding entity for participation in this study. Medhab LLC will assume all costs
associated with the training, application, device and use of the StepRite product for the
full course of this study.
Subjects for this study will be recruited from the patient population seen by the
investigator's during the normal course of business. There will be no outside recruitment of
individuals or advertising as to the presence or use of the monitoring device to entice new
patient referral. Prospective candidates will be asked by the investigator at the time they
are designated surgical candidates. All documentation related to the study will be reviewed
with the patient by the lead physician or his designee who is appropriately trained in
discussing patient recruitment. Final decision and randomization to control or StepRite use
will be done as part of the preoperative checkup just prior to surgery where both operative
consent and study consent are discussed and signed.
Randomization:
Once a patient agrees to the study they would be sequentially randomized into whether or not
they receive StepRite. The patients will be randomized to every other eligible patient gets
the intervention. (ie: 1,3,5,7,9… will get StepRite ; 2,4,6,8 will not get StepRite) 15
Intervention subjects will be recruited and 15 control subjects will be recruited with an
extra 5 patients to account for attrition and withdrawals.
Inclusion Criteria:
- Unilateral partial or total knee arthroplasty.
- Age 45-75 yr. old
- BMI <35
- Access to Wi-Fi
- Have appropriate smart phone and knowledge of use
- Be willing to place StepRite app on their personal phone
Exclusion Criteria:
- History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).
- Pregnancy
- History of cognitive disease that would preclude ability to navigate smart phone
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