Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unassisted manual transfer | this group will use no additional aid in 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unassisted Manual Transfer | Device | No device assistance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Force | measurement of applied shoulder force during wheelchair transfers | None reported - verifiable data is not available for any of the participants |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Candidates who present:
Not provided
Not provided
A sample of 58 veterans with paraplegia who use a rigid manual wheelchair will be recruited to participate in this study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John D Lloyd, PhD BS | James A. Haley Veterans' Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital | Tampa | Florida | 33612-4745 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Although 10 individuals signed ICs, 4 actually actively participated in the study as one was dropped due to an unrelated injury.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Wheelchair Transfer Interventions | 5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One individual was enrolled in the study but withdrew due to an adverse event (hand injury UNRELATED to the study).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Wheelchair Transfer Interventions | Persons with SCI who evaluated wheelchair transfer interventions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shoulder Force | measurement of applied shoulder force during wheelchair transfers | As of the November 2012 update to the IRB, there were no findings at that point. At this time, verifiable data is not available for any of the participants. | Posted | None reported - verifiable data is not available for any of the participants |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | persons with SCI |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | UNRELATED hand injury to the subject while he was at his home |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Lloyd | James A Haley VA, Tampa | 813-624-8986 | john.lloyd2@va.gov |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Transfer Board |
| Device |
Flat surface board |
|
| Glide n' Go | Device | Flip down power lift chair |
|
| Easy Reach lift | Device | Original chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height |
|
| Ryno lift | Device | Lift for the wheelchair |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Easy Reach Lift | As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants. |
| OG003 | Ryno Lift | As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants. |
| OG004 | Unassisted Manual Transfer | As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants. |
|
| 0 |
| 5 |
| 1 |
| 5 |
|
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |