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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00434018
First received: February 8, 2007
Last updated: April 16, 2014
Last verified: April 2014
  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 2
Phase 3

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:


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 ]

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

  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
  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
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: NCT00434018

Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
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
Investigators
Principal Investigator: Shirley Groer, PhD MS VA Central Office - HSR&D, Washington, DC
  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: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Wheelchairs
Safety

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 20, 2014