StepRite Evaluation

• Sponsor: University of Southern California (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02270684
• Collaborator: (none)
• Enrollment: 4
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: StepRite	N/A

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

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness of an Activity-Specific Monitoring Device (StepRite) on Short Term Outcomes in Adults After Total Knee Arthroplasty
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device 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	Device: StepRite; 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
No Intervention: Usual and customary care Participants in this arm will undergo usual care and will not be issued with the StepRite device

Outcome Measures

Primary Outcome Measures

1. Knee Osteoarthritis Outcome Score (KOOS) [Baseline, 4, 10, 24 weeks]

   The KOOS is a validated tool to measure pain and quality of life in patients after TKA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).

• Contralateral degenerative joint disease requiring a TKA.

• Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Christopher Powers, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Powers, Associate Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT02270684
• Other Study ID Numbers: FP00002312; HS-13-00319
• First Posted: Oct 21, 2014
• Last Update Posted: May 11, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Christopher Powers, Associate Professor, University of Southern California: Total Knee Arthroplasty; Home monitoring
• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Arm/Group Title	Device	Usual and Customary Care
Arm/Group Description	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 StepRite: 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	Participants in this arm will undergo usual care and will not be issued with the StepRite device
Period Title: Overall Study
STARTED	1	3
COMPLETED	0	0
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Device	Usual and Customary Care	Total
Arm/Group Description	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 StepRite: 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	Participants in this arm will undergo usual care and will not be issued with the StepRite device	Total of all reporting groups
Overall Participants	1	3	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	1 100%	3 100%	4 100%
Sex: Female, Male (Count of Participants)
Female	1 100%	2 66.7%	3 75%
Male	0 0%	1 33.3%	1 25%
Region of Enrollment (participants) [Number]
United States	1 100%	3 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Knee Osteoarthritis Outcome Score (KOOS)
Description	The KOOS is a validated tool to measure pain and quality of life in patients after TKA
Time Frame	Baseline, 4, 10, 24 weeks

Outcome Measure Data

Analysis Population Description

Due to early termination, no evaluable data was collected

Arm/Group Title	Device	Usual and Customary Care
Arm/Group Description	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 StepRite: 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	Participants in this arm will undergo usual care and will not be issued with the StepRite device
Measure Participants	0	0

Adverse Events

Arm/Group Title	Device		Usual and Customary Care
Arm/Group Description	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 StepRite: 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		Participants in this arm will undergo usual care and will not be issued with the StepRite device
All Cause Mortality
	Device		Usual and Customary Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Device		Usual and Customary Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Device		Usual and Customary Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)

Limitations/Caveats

Early termination lead to no final outcome measures being collected.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.