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Stability Plus - Outcomes From Extended Continuum of Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Stability Plus, LLC.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by:
Stability Plus, LLC
ClinicalTrials.gov Identifier:
NCT00756483
First received: September 18, 2008
Last updated: September 19, 2008
Last verified: September 2008
History of Changes
  Purpose

Basic Protocol

  1. Identify participant(s)
  2. Request patient participation/Acquire Consent

  3. Register patient at www.stabilityplus.net through the LOGIN tab

    • Patient ID (Name/Initials/SSN or any combination thereof)
    • Gender
    • Age
    • Surgical Procedure
    • Date of Surgery
    • Select Basic Exercise Program that corresponds with Surgical Procedure
  4. Perform Initial Assessment using Basic Exercises for the Surgical Procedure
  5. Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)
  6. Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient
  7. Monitor patient progress through Stability Plus portal.

Condition
Arthroplasty

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study the Effects of Pre- and Post-Operative Resistive Exercise in Total Arthroplasty Patients Using the Stability Plus Exercise System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stability Plus, LLC:

Primary Outcome Measures:
  • Pre- and post- study strength assessment tests for joint specific exercises [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduced recovery time versus current norm [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
M, 1
Male patients that have undergone total knee replacement
F, 1
Female patients that have undergone total knee replacement
M, 2
Male patients that have undergone total hip replacement
F, 2
Female patients that have undergone total hip replacement

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients that have undergone total joint replacement - hip or knee

Criteria

Inclusion Criteria:

  • Undergone total joint replacement
  • Must be able to complete pre-operative strength assessment
  • Must be able to exercise using specified resistive bands

Exclusion Criteria:

  • Non-ambulatory patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756483

Contacts
Contact: Ann M Juengermann JuengermannA@health.missouri.edu
Contact: Linda C Landry LandryL@health.missouri.edu

Locations
United States, Missouri
University of Missouri Hospital Not yet recruiting
Columbia, Missouri, United States, 65212
Contact: Linda C Landry         LandryL@health.missouri.edu    
Contact: Ann M Juengermann         JuengermannA@health.missouri.edu    
Principal Investigator: Sean Ellis            
Sponsors and Collaborators
Stability Plus, LLC
University of Missouri-Columbia
Investigators
Study Director: James T Yost Stability Plus, LLC
  More Information

No publications provided

Responsible Party: James Yost/CEO, Stability Plus, LLC
ClinicalTrials.gov Identifier: NCT00756483     History of Changes
Other Study ID Numbers: 1107957-UMC
Study First Received: September 18, 2008
Last Updated: September 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Stability Plus, LLC:
Resistance
Exercise

ClinicalTrials.gov processed this record on May 22, 2013