NCT00645567

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

March 19, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 7, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

March 19, 2008

Results QC Date

February 27, 2015

Last Update Submit

April 5, 2017

Conditions

Keywords

BiomechanicsErgonomicsSpinal Cord InjuryPainShoulder

Outcome Measures

Primary Outcomes (1)

  • Shoulder Force

    measurement of applied shoulder force during wheelchair transfers

    None reported - verifiable data is not available for any of the participants

Study Arms (5)

Unassisted manual transfer

this group will use no additional aid in transfer.

Device: Unassisted Manual Transfer

Standard sliding board transfer

The standard transfer board is a flat surface board designed to bridge the gap that exists with transfers from wheelchair to vehicle and/or other horizontally displaced seating surfaces.

Device: Standard Transfer Board

Glide n' Go Lift

The Glide n' Go lift is a flip down power list seat that enables the person to enter and exit the vehicle by lifting them from their wheelchair up tot eh vehicle seat that they can make an easy transfer into the vehicle. Trunk stability may be required to successfully use the device.

Device: Glide n' Go

Easy Reach lift

The Easy Reach lift seat allows the vehicles original seat to swivel out of the vehicle and lower to wheelchair height. the chair extends far from the vehicle to provide access for a safe, easy transfer.

Device: Easy Reach lift

Ryno lift

The Ryno lift is an under-vehicle list (UVL) system. Using this lift, the wheelchair user is raised into the vehicle cab using independent controls and can then maneuver into a convenient position in the cab. The wheelchair is locked down and the lift stored beneath the vehicle chassis. This technology eliminated the need to store and retrieve a wheelchair during transit.

Device: Ryno lift

Interventions

No device assistance

Unassisted manual transfer

Flat surface board

Standard sliding board transfer

Flip down power lift chair

Glide n' Go Lift

Original chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height

Easy Reach lift
Ryno liftDEVICE

Lift for the wheelchair

Ryno lift

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James A. Haley Veterans' Hospital

Tampa, Florida, 33612-4745, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesPain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

PI has left facility. This study did not yield usable results due to staffing, contracting issues. Although 10 individuals signed ICs, 4 actually actively participated in the study and verifiable data is not available for any of the participants.

Results Point of Contact

Title
John Lloyd
Organization
James A Haley VA, Tampa

Study Officials

  • John D Lloyd, PhD BS

    James A. Haley Veterans' Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 27, 2008

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

December 1, 2012

Last Updated

April 7, 2017

Results First Posted

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations