Stability Plus - Outcomes From Extended Continuum of Care

Arthroplasty Clinical Trial

Official title:

Study the Effects of Pre- and Post-Operative Resistive Exercise in Total Arthroplasty Patients Using the Stability Plus Exercise System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00756483
• Other study ID #: 1107957-UMC
• Status: Not yet recruiting
• Phase: N/A
• First received: September 18, 2008
• Last updated: September 19, 2008
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: September 2008
• Source: Stability Plus, LLC
• Contact: Ann M Juengermann
• Email: JuengermannA[@]health.missouri.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthroplasty

Locations

Country	Name	City	State
United States	University of Missouri Hospital	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Stability Plus, LLC	University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre- and post- study strength assessment tests for joint specific exercises		3 months, 6 months and 12 months	No
Secondary	Reduced recovery time versus current norm		3 months, 6 months and 12 months	No