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Spinal Cord InjuryNCT00645567

Biomechanics of Wheelchair Transfers

An observational study of Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury
What is being tested?
Unassisted Manual Transfer, Standard Transfer Board and Glide n' Go
Type of treatment
Medical device
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2010to Dec 2012
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James A. Haley Veterans' Hospital

    Tampa, Florida, 33612-4745

Other trials in United States

About this study

Official title: Evaluation of Transfer Technologies to Preserve Shoulder Function in SCI

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.

Read the detailed description

Specific Aims:

The purpose of this 3 year laboratory-based randomized crossover study is to evaluate the ergonomic effectiveness of four wheelchair/vehicle transfer assistive devices, including (1) standard transfer board, (2) Glide n' Go, ( 3) Easy Reach Lift, and (4) Ryno Lift, and to compare them to an unassisted manual transfer. We have targeted persons with paraplegia (level of injury T2-L5) to standardize physical capabilities. Our research questions are:

  1. Evaluate the impact of vehicle/wheelchair transfers on objective measures of shoulder kinematics, kinetics, and muscle activity, for each of the participants.
  2. Evaluate the impact of vehicle/wheelchair transfers on subjective measures of shoulder pain, spasticity, perceived comfort, ease, efficiency, and safety.
  3. Examine the effects of covariates (patient characteristics, SCI characteristics and pain) on both objective and subjective outcome measures.

Background:

Upper limb pain and injury are highly prevalent in persons with a spinal cord injury (SCI) who use a manual wheelchair for mobility. Historically, persons with paraplegia did not long survive the trauma of their injury, but with advances in medicine and emergency services, persons with SCI now have a life expectancy approaching that of the general population. For persons with paraplegia, paralysis of the lower limbs necessitates an over reliance on the upper limbs for performing wheelchair propulsion, transfers in/out of the wheelchair, and other mobility-related tasks. Many years of overuse of the upper extremities leads to an increased incidence of pain and cumulative trauma to the shoulders, elbows and wrists. Over 50% of persons with SCI have upper extremity pain; rotator cuff tears have been reported in 59-73%; and 40% have clinical evidence of carpal tunnel syndrome. Upper extremity deterioration following years of compensating for the lack of functional lower limbs in addition to their usual loading reduces quality of life, function, independence, and even life expectancy following SCI. The two most stressful mobility tasks performed by persons with paraplegia are wheelchair propulsion and wheelchair transfers. Several investigators have examined upper extremity kinematics (joint motions) kinetics (joint forces and torques), and muscle activity as determined by electromyography (EMG) among individuals with SCI during wheelchair propulsion. Comparatively few studies have addressed wheelchair transfers none of which offer an integrated kinematic, kinetic and EMG approach to simultaneously examine joint angles, moments and muscle activity.

Methods:

Using Vicon motion analysis technology, we propose a laboratory-based randomized evaluation of five vehicle transfer approaches: unassisted manual transfer, standard transfer board, Glide n'Go, Easy Reach lift, and Ryno lift. The selected commercially-available products represent the range of assistive technologies presently available for this task.

A sample of 58 veterans with paraplegia, who use a manual wheelchair for mobility, will be recruited to participate in this study. Subjects will be recruited from the Tampa VA Hospital by means of poster advertisement. Participants will complete data collection activities during one four-hour session, for which they will be compensated. Subjects will be asked to perform a series of five randomized wheelchair-to-vehicle transfer tasks. Vicon markers placed on the participant's body will capture positional data. Dynamic external loads exerted during the transfer tasks will be measured using AMTI MC3A tri-axial load cells strategically mounted in a vehicle mock-up. EMG will be recorded bilaterally for major muscle groups. Participants will complete subjective rating scales upon completion of each of the transfers.

The results of this study will be used to develop a clinical algorithm to assist clinicians with the selection of the most appropriate assistive technology for persons with disabilities who use a manual wheelchair for mobility. This algorithm will facilitate the individualized selection of assistive technologies that minimize risk for injury and maximize patient compliance, comfort, and satisfaction. The ultimate goal of this program of research is to (1) promote successful adaptation to aging with a disability, (2) reduce morbidity and mortality associated with wheelchair use, (3) enhance health-related quality of life, patient freedom, function, independence, and confidence, and (4) reduce healthcare utilization and associated costs.

Being tested
Unassisted Manual Transfer, Standard Transfer Board, Glide n' Go, Easy Reach lift, Ryno lift
Keywords
Biomechanics, Ergonomics, Spinal Cord Injury, Pain, Shoulder
Medical subject headings
Spinal Cord Injuries, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unassisted Manual TransferDevice

    No device assistance

  • Standard Transfer BoardDevice

    Flat surface board

  • Glide n' GoDevice

    Flip down power lift chair

  • Easy Reach liftDevice

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

  • Ryno liftDevice

    Lift for the wheelchair

Study groups in NCT00645567
Study groupRoleWhat they receive
Unassisted manual transferthis group will use no additional aid in transfer.
Receives: Device: Unassisted Manual Transfer
Standard sliding board transferThe 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.
Receives: Device: Standard Transfer Board
Glide n' Go LiftThe 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.
Receives: Device: Glide n' Go
Easy Reach liftThe 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.
Receives: Device: Easy Reach lift
Ryno liftThe 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.
Receives: Device: Ryno lift

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shoulder Force

    measurement of applied shoulder force during wheelchair transfers

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2008 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00645567
Sponsor's protocol ID
B6103-R
Status last verified
Apr 2017
First submitted
19 Mar 2008
Last updated
7 Apr 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Force (time frame: None reported - verifiable data is not available for any of the participants). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.

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