Clinical trial NCT00434018: Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI)
Official title: Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injury
Keywords: Wheelchairs
Safety
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-02-12
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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

Primary outcomes:
measure: Wheelchair Skills Test (WST)
timeFrame: long term (1 year)
Secondary outcomes:
measure: Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale
timeFrame: long term (1 year)
measure: Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale
timeFrame: long term (1 year)
measure: Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale
timeFrame: long term (1 year)
measure: Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale
timeFrame: long term (1 year)
measure: Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale
timeFrame: long term (1 year)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Augusta
country: United States
facility: VA Medical Center, Augusta
state: Georgia
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Shirley Groer, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: