Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI)

Status: Completed
Study State Date: April 2008
Primary Completion Date: Actual September 2011
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Phase: Phase 2/Phase 3

Sponsor(s):
Department of Veterans Affairs
 
Information By: Department of Veterans Affairs
Trial Identifier: NCT00434018
Official Title: Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI

Description:  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.

+ Additional Objectives Detail

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: 1. Determine the immediate and sustained effects of a WSTP on ability, performance time, and physical strain. 2. Examine the effects of mediating and moderating variables on ability, performance time, and physical strain. 3. Examine the effects of a WSTP on safety, community participation, and quality of life. 4. 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



Accepts Healthy Volunteers?: Accepts Healthy Volunteers
Enrollment: 160 Anticipated
Minimum Age: 18 Years
Maximum Age: 75 Years
Gender(s): Both
Additional 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

Conditions:
Spinal Cord Injury
Spinal Cord Injuries
Interventions:
Behavioral: Wheelchair Skills Training
Behavioral: Basic health educational training sessions
 
Primary Outcome Measures:
Wheelchair skill (ability and safety)
Time Frame: immediate (6 weeks) and long term (1 year) - both post training
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
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Arm 1: Other
wheelchair skills training
Behavioral: Wheelchair Skills Training
Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.

 
Arm 2: Other
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

 


Investigators:
Principal Investigator: Shirley Groer, PhD MS, VA Central Office - HSR&D, Washington, DC


Study Locations:
+ Show All 3 Study Locations


United States, Florida
James A. Haley Veterans' Hospital 
Tampa, Florida, United States



United States, Georgia
VA Medical Center, Augusta 
Augusta, Georgia, United States



United States, Massachusetts
VA Medical Center, Jamaica Plain Campus 
Boston, Massachusetts, United States

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