Study Stopped
Recruitment and retention difficulties
StepRite Evaluation
Comparative Effectiveness of an Activity-Specific Monitoring Device (StepRite) on Short Term Outcomes in Adults After Total Knee Arthroplasty
2 other identifiers
interventional
4
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
May 11, 2017
CompletedMay 11, 2017
April 1, 2017
8 months
October 17, 2014
May 10, 2016
April 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Osteoarthritis Outcome Score (KOOS)
The KOOS is a validated tool to measure pain and quality of life in patients after TKA
Baseline, 4, 10, 24 weeks
Study Arms (2)
Device
EXPERIMENTALParticipants 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 INTERVENTIONParticipants in this arm will undergo usual care and will not be issued with the StepRite device
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).
- Contralateral degenerative joint disease requiring a TKA.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination lead to no final outcome measures being collected.
Results Point of Contact
- Title
- Dr Christopher Powers
- Organization
- University of Southern California
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Powers, PhD
University of Southern California
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 21, 2014
Study Start
May 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
May 11, 2017
Results First Posted
May 11, 2017
Record last verified: 2017-04