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

NCT ID: NCT00434018

Last Updated: 2015-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

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:

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

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Wheelchair Skills Training

Intervention Type BEHAVIORAL

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

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.

Group Type OTHER

Basic Health Education

Intervention Type BEHAVIORAL

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

Interventions

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Wheelchair Skills Training

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shirley Groer, PhD MS

Role: PRINCIPAL_INVESTIGATOR

James A. Haley Veterans' Hospital, Tampa, FL

Locations

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James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Site Status

VA Medical Center, Augusta

Augusta, Georgia, United States

Site Status

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IIR 06-274

Identifier Type: -

Identifier Source: org_study_id

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