NCT00434018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2008

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

3.4 years

First QC Date

February 8, 2007

Results QC Date

September 16, 2014

Last Update Submit

April 24, 2015

Conditions

Keywords

WheelchairsSafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale

    long term (1 year)

  • Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale

    long term (1 year)

  • Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale

    long term (1 year)

  • Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale

    long term (1 year)

  • Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale

    long term (1 year)

Study Arms (2)

Wheelchair Skills Training Program

OTHER

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

Basic Health Education

OTHER

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

Interventions

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

Wheelchair Skills Training Program

Five sessions are held with subjects to provide them with educational information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc.

Basic Health Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

VA Medical Center, Augusta

Augusta, Georgia, 30904, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Shirley Groer
Organization
VACO

Study Officials

  • Shirley Groer, PhD MS

    James A. Haley Veterans' Hospital, Tampa, FL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

April 1, 2008

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

May 12, 2015

Results First Posted

October 6, 2014

Record last verified: 2015-04

Locations