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Biomechanics of Wheelchair Transfers
This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, July 2009
First Received: March 19, 2008   Last Updated: July 22, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00645567
  Purpose

This is a laboratory-based study to evaluate the risk of shoulder injury associated with transfers between wheelchair and vehicle in persons with spinal cord injury. Four new devices will be compared against an unassisted transfer.


Condition
SCI
Spinal Cord Injury

Study Type: Observational
Study Design: Case-Crossover, Cross-Sectional
Official Title: Evaluation of Transfer Technologies to Preserve Shoulder Function in SCI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Shoulder kinematics & kinetics [ Time Frame: Calculated during task performance for each of the 5 devices tested ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 58
Study Start Date: October 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

A sample of 58 veterans with paraplegia who use a rigid manual wheelchair will be recruited to participate in this study.

Criteria

Inclusion Criteria:

  • level of SCI will be limited to ASIA A classification at T2 through L5 level to standardize physical capabilities,
  • SCI for at least 2 years (neurologically stable,
  • use rigid manual wheelchair as a primary means of mobility,
  • able to self-propel wheelchair,
  • able to independently transfer between wheelchair and vehicle,
  • between the ages of 18-65,
  • living in the community within 100 miles of the Tampa VA hospital,
  • able to follow simple instructions,
  • free from acute upper extremity injury for at least six months (determined by chart review) to minimize risk of injury during task performance,
  • comparable bilateral functional range of motion and strength of the shoulders, elbows and wrists (determined by physical evaluation) to minimize risk of injury during task performance.

Exclusion Criteria:

Candidates who present:

  • 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 of power wheelchair or scooter as primary means of mobility,
  • pregnancy,
  • clinical evidence of severe musculoskeletal disorders of the upper extremity will be precluded from participating in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645567

Contacts
Contact: John D Lloyd, PhD (813) 558-3925 john.lloyd2@va.gov

Locations
United States, Florida
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Investigators
Principal Investigator: John D. Lloyd, PhD James A. Haley Veterans Hospital, Tampa
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Lloyd, John - Principal Investigator )
Study ID Numbers: B6103R
Study First Received: March 19, 2008
Last Updated: July 22, 2009
ClinicalTrials.gov Identifier: NCT00645567     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Biomechanics
Ergonomics
SCI
Pain
Shoulder

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Pain
Trauma, Nervous System

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 10, 2009