Effects of Mobility Devices on Nursing Compliance With Mobility Protocols (EMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Saint Joseph Mercy Health System
Sponsor:
Information provided by (Responsible Party):
Mary-Anne Purtill, Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT01690910
First received: August 31, 2012
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of critically ill ventilator dependent patients in the intensive care units (ICUs) and improve important patient outcomes. The pilot study is designed to assess the feasibility and logistics of doing a study of this nature in the ICU; it will also provide the means to obtain estimates of outcome effect sizes, number of repeated measures, time between repeated measures, and intra-subject and intra-unit correlations, to be used for sample size calculations.


Condition Intervention
Mobility of Critical Care Ventilated Patients.
Device: Rifton Gait Trainer
Device: Front Wheeled Walker

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Mobility Devices on Nursing Compliance With Mobility Protocols.

Resource links provided by NLM:


Further study details as provided by Saint Joseph Mercy Health System:

Primary Outcome Measures:
  • Total number of times the critically ill ventilator dependent patient is mobilized. [ Time Frame: Duration of Intensive Care Unit Stay (2-30 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of time the critically ill ventilator dependent patient is mobilized. [ Time Frame: Patient weight baring to patient seated (1-12 minutes) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Front Wheeled Walker
The Front Wheeled Walker is a standard walker that is used to assist patients while walking.
Device: Front Wheeled Walker
Active Comparator: Rifton Gait Trainer
The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.
Device: Rifton Gait Trainer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years of age
  • On the ventilator for > 48 hours
  • Mobility score > 3

Exclusion Criteria:

  • > 220 lbs
  • Limb amputees
  • Prisoners
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690910

Contacts
Contact: Suzanne Winter, MS 734-712-7509 winters@trinity-health.org
Contact: Felicia Formosa, BS 734-712-5396 formosaf@trinity-health.org

Locations
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Suzanne Winter, MS    734-712-7509    winters@trinity-health.org   
Contact: Felicia Formosa, BS    734-712-5396    formosaf@trinity-health.org   
Principal Investigator: Mary-Anne Purtill, MD         
Sponsors and Collaborators
Saint Joseph Mercy Health System
Investigators
Principal Investigator: Mary-Anne Purtill, MD Saint Joseph Mercy Health System
  More Information

Publications:

Responsible Party: Mary-Anne Purtill, Critical Care Trauma Surgeon, Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT01690910     History of Changes
Other Study ID Numbers: RCAY 40
Study First Received: August 31, 2012
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Joseph Mercy Health System:
Ventilator
Mobility Limitations
Critical Care
Rifton Gait Trainer

ClinicalTrials.gov processed this record on July 20, 2014