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

Spinal Cord Injury Clinical Trial

Official title:

Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434018
• Other study ID #: IIR 06-274
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 8, 2007
• Last updated: April 24, 2015
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center, Augusta	Augusta	Georgia
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No