Effects of Mobility Devices on Nursing Compliance With Mobility Protocols

NCT01690910 | Terminated Results

• 1 other identifier: RCAY 40
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobility Limitations

Keywords

Ventilator; Mobility Limitations; Critical Care; Rifton Gait Trainer

Outcome Measures

Primary Outcomes (1)

• Total Number of Times the Critically Ill Ventilator Dependent Patient is Mobilized.

  Duration of Intensive Care Unit Stay (2-30 days)

Secondary Outcomes (1)

• Length of Time the Critically Ill Ventilator Dependent Patient is Mobilized.

  Patient weight baring to patient seated (1-12 minutes)

Study Arms (2)

Front Wheeled Walker

ACTIVE COMPARATOR

The Front Wheeled Walker is a standard walker that is used to assist patients while walking.

Device: Front Wheeled Walker

Rifton Gait Trainer

ACTIVE COMPARATOR

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

Interventions

Rifton Gait Trainer DEVICE

Rifton Gait Trainer

Front Wheeled Walker DEVICE

Front Wheeled Walker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \> 220 lbs
• Limb amputees
• Prisoners
• Pregnant women

Sponsors & Collaborators

• Trinity Health Michigan: lead

Study Sites (1)

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (9)

• Hopkins RO, Spuhler VJ, Thomsen GE. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007 Jan;23(1):81-96. doi: 10.1016/j.ccc.2006.11.004.

  PMID: 17307118 BACKGROUND

• Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.

  PMID: 17133183 BACKGROUND

• Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

  PMID: 12594312 BACKGROUND

• Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.

  PMID: 20382284 BACKGROUND

• Fan E, Zanni JM, Dennison CR, Lepre SJ, Needham DM. Critical illness neuromyopathy and muscle weakness in patients in the intensive care unit. AACN Adv Crit Care. 2009 Jul-Sep;20(3):243-53. doi: 10.1097/NCI.0b013e3181ac2551.

  PMID: 19638746 BACKGROUND

• Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.

  PMID: 18840842 BACKGROUND

• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.

  PMID: 18596631 BACKGROUND

• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 BACKGROUND

• Needham DM, Wang W, Desai SV, Mendez-Tellez PA, Dennison CR, Sevransky J, Shanholtz C, Ciesla N, Spillman K, Pronovost PJ. Intensive care unit exposures for long-term outcomes research: development and description of exposures for 150 patients with acute lung injury. J Crit Care. 2007 Dec;22(4):275-84. doi: 10.1016/j.jcrc.2007.02.001. Epub 2007 Jun 27.

  PMID: 18086397 BACKGROUND

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amy Burghardt
• Organization: St. Joseph Mercy Hospital

amy.burghardt@stjoeshealth.org

734-712-2027

Study Officials

• MaryAnne Purtill, MD

  St. Jospeh Mercy Hospital

  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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)