Biomechanics of Wheelchair Transfers

NCT ID: NCT00645567

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Spinal Cord Injury

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Unassisted manual transfer

this group will use no additional aid in transfer.

Unassisted Manual Transfer

Intervention Type: DEVICE

No device assistance

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.

Standard Transfer Board

Intervention Type: DEVICE

Flat surface 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.

Glide n' Go

Intervention Type: DEVICE

Flip down power lift chair

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.

Easy Reach lift

Intervention Type: DEVICE

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

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.

Ryno lift

Intervention Type: DEVICE

Lift for the wheelchair

Interventions

Unassisted Manual Transfer

No device assistance

Intervention Type: DEVICE

Standard Transfer Board

Flat surface board

Intervention Type: DEVICE

Glide n' Go

Flip down power lift chair

Intervention Type: DEVICE

Easy Reach lift

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

Intervention Type: DEVICE

Ryno lift

Lift for the wheelchair

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D Lloyd, PhD BS

Role: PRINCIPAL_INVESTIGATOR

James A. Haley Veterans' Hospital

Locations

James A. Haley Veterans' Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

B6103-R

Identifier Type: -

Identifier Source: org_study_id