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

Study Overview
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Brief Summary
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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
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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: Determine the immediate and sustained effects of a WSTP on ability, performance time, and physical strain. Examine the effects of mediating and moderating variables on ability, performance time, and physical strain. Examine the effects of a WSTP on safety, community participation, and quality of life. 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

Official Title
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Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Behavioral: Wheelchair Skills Training
* Behavioral: Basic Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wheelchair Skills Training Program<br>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<br>* Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.<br>|
| Other: Basic Health Education<br>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<br>* Five sessions are held with subjects to provide them with educational information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Wheelchairs