Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI) - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00434018

Purpose

We propose to test an evidence-based wheelchair skills training program to optimize wheelchair safety and performance in veterans with SCI. The proposed training program incorporates emerging evidence on wheelchair biomechanics and motor-skills learning, and addresses recommendations in a new clinical practice guideline. Given the difficulty in translating wheelchair skills learned in a therapy clinic with "real world" problems in the home and community post-discharge, we are proposing to conduct the wheelchair skills training in and around the veteran's home. The immediate goal is to enhance ability, performance time, safety, community participation, and quality of life, while minimizing physical strain. The ultimate goal is to reduce morbidity/mortality associated with wheelchair use and promote successful aging with a disability.

Condition	Intervention	Phase
Spinal Cord Injury	Behavioral: Wheelchair Skills Training Behavioral: Basic health educational training sessions	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Wheelchair skill (ability and safety) [ Time Frame: immediate (6 weeks) and long term (1 year) - both post training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Community participation; Environmental barriers; quality of life; physical strain; distance traveled [ Time Frame: immediate (6 weeks) and long term (1 year) - both post training ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	April 2008
Study Completion Date:	December 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 wheelchair skills training	Behavioral: Wheelchair Skills Training Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
2 education on health related issues	Behavioral: Basic health educational training sessions Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc

Detailed Description:

The purpose of this 3-year randomized controlled clinical trial is to evaluate use of a community-based wheelchair skills training program (WSTP). Objectives include:

Determine the immediate and sustained effects of a WSTP on ability, performance time, and physical strain.
Examine the effects of mediating and moderating variables on ability, performance time, and physical strain.
Examine the effects of a WSTP on safety, community participation, and quality of life.
Promote dissemination of WSTP in VA SCI Centers through two key activities: (a) Design innovative marketing plans to increase participation and promote patient-centeredness based on patient-perceived benefits. (b) Estimate health care resources needed to add home-based

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

SCI for at least 1 year (neurologically stable)
Level of injury: C6 and below who use manual wheelchair as a primary means of mobility
Able to self-propel wheelchair
Between the ages of 18-75
Able to follow simple instructions

Exclusion Criteria:

Progressive disease (e.g. spinal tumor)
Extended bedrest for more than 30 days
Ventilator-dependent
Any cardiac or respiratory condition that would limit subject's physical performance
Unstable medical conditions
Use power wheelchair or scooter as primary means of mobility
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434018

Locations

United States, Florida
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33637-1022
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Shirley Groer, PhD MS

James A. Haley Veterans Hospital

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00434018 History of Changes
Other Study ID Numbers:	IIR 06-274
Study First Received:	February 8, 2007
Last Updated:	January 27, 2012
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Wheelchairs
Safety

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012