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Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite

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ClinicalTrials.gov Identifier: NCT02900781
Recruitment Status : Terminated (Participants were unable to use the device. No data was collected)
First Posted : September 14, 2016
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
MedHab, LC
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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


Condition or disease Intervention/treatment Phase
Osteoarthritis Degenerative Joint Disease Device: Steprite™ Other: Standard of care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite - on Short Term Outcomes in Adults After Partial or Total Knee Arthroplasty
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Comparator Steprite™ Device'
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™
Steprite™ Device shoe insert monitoring device
Other Name: steprite™ System Device

Placebo Comparator: Control
Control outcomes with no device. Standard of care physical therapy and outcomes.
Other: Standard of care
No Device. Standard of care physical therapy




Primary Outcome Measures :
  1. Effectiveness of Step Rite Device [ Time Frame: 3 months ]
    Effectiveness of outcomes with the use of the StepRite device



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900781


Locations
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United States, Texas
TTUHSC Orthopaedic Surgery MS 9436
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
MedHab, LC
Investigators
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Principal Investigator: George W Brindley, MD TTUHSC
  Study Documents (Full-Text)

Documents provided by Texas Tech University Health Sciences Center:

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02900781     History of Changes
Other Study ID Numbers: L16-138
First Posted: September 14, 2016    Key Record Dates
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Texas Tech University Health Sciences Center:
Arthroplasty
Physical Therapy
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases