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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: October 6, 2014
Last verified: October 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 Education
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 Skills Test (WST) [ Time Frame: long term (1 year) ] [ Designated as safety issue: No ]
    The WST is a standardized evaluation method that permits a set of representative wheelchair skills to be objectively, simply and inexpensively documented. The WST is an instrument for the objective evaluation of wheelchair skills. The WST consists of a series of commonly used wheelchair skills spanning the spectrum from those as basic as applying brakes to those as difficult as climbing curbs and performing wheelies. The WSC encompasses 57 skills (in Version 4.1) which result in a total score. The WST provide a pass-fail score for each skill. Refusal to attempt a skill (e.g. because of fear) constitutes a failing grade. The numerator is the Total Raw Score (i.e., the number of individual skills awarded a passing score) and the denominator is the number of applicable skills (i.e., the total number of skills minus those awarded NP scores). 100% is the maximum possible percentage score.


Secondary Outcome Measures:
  • Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale [ Time Frame: long term (1 year) ] [ Designated as safety issue: No ]
    Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Physical Independence subscale measures the ability to sustain a customarily effective independent existence.

  • Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale [ Time Frame: long term (1 year) ] [ Designated as safety issue: No ]
    Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Mobility Subscale measures the ability to move about effectively in his/her surroundings.

  • Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale [ Time Frame: long term (1 year) ] [ Designated as safety issue: No ]
    Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Occupation Subscale measures the ability to occupy time in the manner customary to that person's sex, age, and culture.

  • Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale [ Time Frame: long term (1 year) ] [ Designated as safety issue: No ]
    Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Social Integration Subscale measures the ability to participate in and maintain customary social relationships.

  • Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale [ Time Frame: long term (1 year) ] [ Designated as safety issue: No ]
    Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Economic Self-Sufficiency subscale measures the ability to sustain customary socio-economic activity and independence.


Enrollment: 138
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
Wheelchair Skills Training Program
Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
Behavioral: Wheelchair Skills Training
Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
Basic Health Education
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.
Behavioral: Basic Health Education
Five sessions are held with subjects to provide them with educational 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 - RR&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
Results First Received: September 16, 2014
Last Updated: October 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Wheelchairs
Safety

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

ClinicalTrials.gov processed this record on November 25, 2014