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.
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,
Show all 10Show fewer
- 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,
Show all 9Show fewer
- 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
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:
- Evaluate the impact of vehicle/wheelchair transfers on objective measures of shoulder kinematics, kinetics, and muscle activity, for each of the participants.
- Evaluate the impact of vehicle/wheelchair transfers on subjective measures of shoulder pain, spasticity, perceived comfort, ease, efficiency, and safety.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Unassisted manual transfer | this group will use no additional aid in transfer. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Ryno lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted27 Mar 2008 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D Lloyd, PhD BS, Principal investigator, James A. Haley Veterans' Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transfer Technologies to Preserve Shoulder Function in SCI
- ClinicalTrials.gov ID
- NCT00645567
- Acronym / sponsor ID
- B6103-R
- Conditions
- Spinal Cord Injury
- Keywords
- Biomechanics, Ergonomics, Spinal Cord Injury, Pain, Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the impact of vehicle/wheelchair transfers on objective measures of shoulder kinematics, kinetics, and muscle activity, for each of the participants.
- Evaluate the impact of vehicle/wheelchair transfers on subjective measures of shoulder pain, spasticity, perceived comfort, ease, efficiency, and safety.
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Unassisted manual transfer | – | Device: Unassisted Manual Transferthis group will use no additional aid in transfer. |
| Standard sliding board transfer | – | Device: Standard Transfer BoardThe 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 | – | Device: Glide n' GoThe 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 | – | Device: 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. |
| Ryno lift | – | Device: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unassisted Manual TransferNo device assistance | Device | Unassisted manual transfer |
| Standard Transfer BoardFlat surface board | Device | Standard sliding board transfer |
| Glide n' GoFlip down power lift chair | Device | Glide n' Go Lift |
| Easy Reach liftOriginal chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height | Device | Easy Reach lift |
| Ryno liftLift for the wheelchair | Device | Ryno lift |
Primary outcome
Shoulder Force
Time frame: None reported - verifiable data is not available for any of the participants
measurement of applied shoulder force during wheelchair transfers
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Lloyd, PhD BS principal investigator
James A. Haley Veterans' Hospital
1 site in 1 country: see every site and its status.
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.