Trial Outcomes & Findings for Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite (NCT NCT02900781)

NCT ID: NCT02900781

Last Updated: 2019-08-09

Results Overview

Effectiveness of outcomes with the use of the StepRite device

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

3 months

Results posted on

2019-08-09

Participant Flow

Consented participants

StudyTerminated- device not working

Participant milestones

Participant milestones
Measure	Control Control outcomes with no device. Standard of care physical therapy and outcomes. Standard of care: No Device. Standard of care physical therapy	Device Device group- Standard of Care with the device
Overall Study STARTED	4	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator Steprite™ Device' n=5 Participants 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™: Steprite™ Device shoe insert monitoring device	Control n=4 Participants Control outcomes with no device. Standard of care physical therapy and outcomes. Standard of care: No Device. Standard of care physical therapy	Total n=9 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Partial or Total Knee Arthroplasty	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Study Terminated due to device not working at our site. No data collected

Effectiveness of outcomes with the use of the StepRite device

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Swinford CCRC

Texas Tech University Health Sciences Center

Phone: 8067432569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place