Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02900781|
Recruitment Status : Terminated (Participants were unable to use the device. No data was collected)
First Posted : September 14, 2016
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Degenerative Joint Disease||Device: Steprite™ Other: Standard of care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite - on Short Term Outcomes in Adults After Partial or Total Knee Arthroplasty|
|Actual Study Start Date :||October 21, 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Active Comparator: Active Comparator Steprite™ Device'
steprite™ device active Comparator- The steprite™ System is a monitoring and biofeedback system for the Monitoring of rehabilitation patients Measuring pressure distribution, gait and range of motion of the lower extremities while a patient performs specified rehabilitation exercises
Steprite™ Device shoe insert monitoring device
Other Name: steprite™ System Device
Placebo Comparator: Control
Control outcomes with no device. Standard of care physical therapy and outcomes.
Other: Standard of care
No Device. Standard of care physical therapy
- Effectiveness of Step Rite Device [ Time Frame: 3 months ]Effectiveness of outcomes with the use of the StepRite device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900781
|United States, Texas|
|TTUHSC Orthopaedic Surgery MS 9436|
|Lubbock, Texas, United States, 79430|
|Principal Investigator:||George W Brindley, MD||TTUHSC|