Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite

NCT02900781 | Terminated Results

• 1 other identifier: L16-138
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis; Degenerative Joint Disease

Keywords

Arthroplasty; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Step Rite Device

  Effectiveness of outcomes with the use of the StepRite device

  3 months

Study Arms (2)

Active Comparator Steprite™ Device'

ACTIVE COMPARATOR

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

Device: Steprite™

Control

PLACEBO COMPARATOR

Control outcomes with no device. Standard of care physical therapy and outcomes.

Other: Standard of care

Interventions

Steprite™ DEVICE

Steprite™ Device shoe insert monitoring device

Also known as: steprite™ System Device

Active Comparator Steprite™ Device'

Standard of care OTHER

No Device. Standard of care physical therapy

Control

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral partial or total knee arthroplasty.
• Age 45-75 yr. old
• BMI \<35
• Access to Wi-Fi
• Have appropriate smart phone and knowledge of use
• Be willing to place StepRite app on their personal phone

You may not qualify if:

• History of neuromuscular disorder (e.g. Parkinson's, Polio, or stroke).
• Pregnancy
• History of cognitive disease that would preclude ability to navigate smart phone

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead
• MedHab, LC: collaborator

Study Sites (1)

TTUHSC Orthopaedic Surgery MS 9436

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Nancy Swinford CCRC
• Organization: Texas Tech University Health Sciences Center

nancy.swinford@ttuhsc.edu

8067432569

Study Officials

• George W Brindley, MD

  TTUHSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 14, 2016
• Study Start: October 21, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)