Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI)
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00434018
First received: February 8, 2007
Last updated: January 24, 2013
Last verified: August 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Behavioral: Wheelchair Skills Training Behavioral: Basic health educational training sessions |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Enhancing Indoor, Community, and Advanced Wheelchair Skills in SCI |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Wheelchair skill (ability and safety) [ Time Frame: immediate (6 weeks) and long term (1 year) - both post training ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Community participation; Environmental barriers; quality of life; physical strain; distance traveled [ Time Frame: immediate (6 weeks) and long term (1 year) - both post training ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1
wheelchair skills training
|
Behavioral: Wheelchair Skills Training
Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
|
|
Arm 2
education on health related issues
|
Behavioral: 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
|
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:
- 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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434018
Locations
| United States, Florida | |
| James A. Haley Veterans Hospital | |
| Tampa, Florida, United States, 33637-1022 | |
| United States, Georgia | |
| VA Medical Center, Augusta | |
| Augusta, Georgia, United States, 30904 | |
| United States, Massachusetts | |
| VA Medical Center, Jamaica Plain Campus | |
| Boston, Massachusetts, United States, 02130 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Shirley Groer, PhD MS | James A. Haley Veterans Hospital |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00434018 History of Changes |
| Other Study ID Numbers: | IIR 06-274 |
| Study First Received: | February 8, 2007 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Wheelchairs Safety |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013