Trial Outcomes & Findings for StepRite Evaluation (NCT NCT02270684)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline, 4, 10, 24 weeks

Results posted on

2017-05-11

Participant milestones
Measure	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 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	Usual and Customary Care Participants in this arm will undergo usual care and will not be issued with the StepRite device
Overall Study STARTED	1	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal
Measure	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 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	Usual and Customary Care Participants in this arm will undergo usual care and will not be issued with the StepRite device
Overall Study Lost to Follow-up	0	3
Overall Study Study terminated	1	0

StepRite Evaluation

Baseline characteristics by cohort
Measure	Device n=1 Participants 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	Usual and Customary Care n=3 Participants Participants in this arm will undergo usual care and will not be issued with the StepRite device	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants

Timeframe: Baseline, 4, 10, 24 weeks

Population: Due to early termination, no evaluable data was collected

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

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Southern California

Phone: 3234422900