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Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite

NCT02900781 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-08-09

Study results available
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Summary

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

Conditions

Interventions

DEVICE

Steprite™

Steprite™ Device shoe insert monitoring device

OTHER

Standard of care

No Device. Standard of care physical therapy

Sponsors & Collaborators

  • MedHab, LC

    collaborator INDUSTRY

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • George W Brindley, MD · TTUHSC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-21
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900781 on ClinicalTrials.gov