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

Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434018

Enrollment

138

Registered

2007-02-12

Start date

2008-04-30

Completion date

2011-12-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Wheelchairs, Safety

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

Interventions

BEHAVIORALWheelchair Skills Training

Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.

BEHAVIORALBasic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Wheelchair Skills Test (WST)	long term (1 year)	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

Measure	Time frame	Description
Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale	long term (1 year)	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	long term (1 year)	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	long term (1 year)	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	long term (1 year)	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	long term (1 year)	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.

Countries

United States

Participant flow

Recruitment details

Recruitment intervals at each site were as follows: 4/08-8/10 at Tampa, 6/08-8/10 at Boston, and 11/08-10/09 at Augusta. Recruitment efforts included posters in VA elevators and in clinic waiting rooms, study brochures, and/or referral of subject by primary care physicians.

Participants by arm

Arm	Count
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.	69
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	69
Total	138

Baseline characteristics

Characteristic	Wheelchair Skills Training Program	Basic Health Education	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	8 Participants	6 Participants	14 Participants
Age, Categorical Between 18 and 65 years	61 Participants	63 Participants	124 Participants
Age, Continuous	46.0 years STANDARD_DEVIATION 13.5	45.3 years STANDARD_DEVIATION 13	45.7 years STANDARD_DEVIATION 13.2
Region of Enrollment United States	69 participants	69 participants	138 participants
Sex: Female, Male Female	5 Participants	5 Participants	10 Participants
Sex: Female, Male Male	64 Participants	64 Participants	128 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 69	0 / 69
serious Total, serious adverse events	8 / 69	5 / 69

Outcome results

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.