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

Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: Wheelchair Skills Training; Behavioral: Basic Health Education

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

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • James A. Haley Veterans' Hospital, Tampa, FL
  • Georgia
    • Augusta, Georgia, United States, 30904
      • VA Medical Center, Augusta
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Medical Center, Jamaica Plain Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wheelchair Skills Test (WST)	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.	long term (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale	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.	long term (1 year)
Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale	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.	long term (1 year)
Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale	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.	long term (1 year)
Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale	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.	long term (1 year)
Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale	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.	long term (1 year)

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Shirley Groer, PhD MS, James A. Haley Veterans' Hospital, Tampa, FL

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 8, 2007
• First Submitted That Met QC Criteria: February 9, 2007
• First Posted (Estimate): February 12, 2007

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Wheelchairs
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: IIR 06-274