Trial Outcomes & Findings for Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI) (NCT NCT00434018)

Last Updated: 2015-05-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

138 participants

Primary outcome timeframe

long term (1 year)

Results posted on

2015-05-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	69	69
Overall Study COMPLETED	52	57
Overall Study NOT COMPLETED	17	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wheelchair Skills Training Program n=69 Participants 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.	Basic Health Education n=69 Participants 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	Total n=138 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 13.5 • n=5 Participants	45.3 years STANDARD_DEVIATION 13 • n=7 Participants	45.7 years STANDARD_DEVIATION 13.2 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	63 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	64 Participants n=7 Participants	128 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	69 participants n=7 Participants	138 participants n=5 Participants

PRIMARY outcome

Timeframe: long term (1 year)

Outcome measures

Outcome measures
Measure	Wheelchair Skills Training Program n=52 Participants 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.	Basic Health Education n=57 Participants 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
Wheelchair Skills Test (WST)	90.4 units on a scale Standard Deviation 11.2	89.6 units on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wheelchair Skills Training Program n=52 Participants 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.	Basic Health Education n=57 Participants 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
Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale	91 units on a scale Standard Deviation 19	91 units on a scale Standard Deviation 15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wheelchair Skills Training Program n=52 Participants 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.	Basic Health Education n=57 Participants 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
Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale	93.7 units on a scale Standard Deviation 13.7	92.8 units on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wheelchair Skills Training Program n=52 Participants 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.	Basic Health Education n=57 Participants 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
Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale	75.1 units on a scale Standard Deviation 30.7	73.5 units on a scale Standard Deviation 29.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wheelchair Skills Training Program n=52 Participants 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.	Basic Health Education n=57 Participants 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
Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale	90 units on a scale Standard Deviation 15.7	90.5 units on a scale Standard Deviation 18.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wheelchair Skills Training Program n=52 Participants 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.	Basic Health Education n=57 Participants 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
Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale	82.4 units on a scale Standard Deviation 33.9	86.5 units on a scale Standard Deviation 26.6

Adverse Events

Wheelchair Skills Training

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Basic Health Education

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Wheelchair Skills Training n=69 participants at risk Wheelchair Skills Training: Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.	Basic Health Education n=69 participants at risk 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
Musculoskeletal and connective tissue disorders Hospitalization due to infected ankle wound	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
General disorders Hospitalization due to depression and acute alcohol Intoxication	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
General disorders Hospitalization due to chronic heel/knee ulcers and heavy alcohol consumption	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
General disorders Hospitalization due to fever and possible infection	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
Infections and infestations Hospitalization due to pneumonia	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
Investigations Hospitalization for colonoscopy screening	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to fever and nausea	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
Infections and infestations Hospitalization due to fever and infection	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
General disorders Hospitalization due to bleeding colostomy and urinary tract infection	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
Renal and urinary disorders Hospitalization due to urinary tract infection	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
Infections and infestations Hospitalization due to infected right foot pressure ulcer	0.00% 0/69 • Study duration, up to 1 year.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.
Surgical and medical procedures Hospitalization due to bladder stone	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
Injury, poisoning and procedural complications Hospitalization due to wound re-opening	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
Surgical and medical procedures Hospitalization due to surgical incision re-opening	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
Investigations Hospitalization due to bladder biopsy and cystoscopy	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to emesis and dehydration	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to stroke/mental status change	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to fever and urinary tract infection	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to pneumonia and altered mental status	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to mental status change and dehydration	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalized for fever and confusion	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalized for pneumonia, leukocytosis, fever and UTI.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalized for mental status changes, vomiting blood and dehydration.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalized for fever, chills, and nephrostomy tube placement for kidney stone/IV anti	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
General disorders Hospitalization due to change in mental status and declining health	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.
Surgical and medical procedures Hospitalization due to hand surgery.	1.4% 1/69 • Number of events 1 • Study duration, up to 1 year.	0.00% 0/69 • Study duration, up to 1 year.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shirley Groer

VACO

Phone: 202-553-9899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place