ParaplegiaNCT00785278
Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion
An observational study of Paraplegia and Upper Limb Pain, run by Kessler Foundation at 1 site in United States.
Trial summary
Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Paraplegia, Upper Limb Pain
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of Northern New Jersey and the surrounding area and/or the patient population of the Kessler Medical Rehabilitation Research and Education Center (KMRREC). Subjects will be recruited from database search and word of mouth.
Who may be able to join
- Have a neurological impairment secondary to a spinal cord injury which occurred over 1 year prior to the start of the study;
- SCI at or below T1 (complete or incomplete);
- Use a manual wheelchair as a primary means of mobility (at least 40 hrs. per week but not necessarily always in motion);
- SCI after age 18
- Have 24 inch diameter wheels with quick-release axles.
- Be between the ages of 18 and 65 years of age.
Who cannot join
- History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
- Upper limb dysthetic pain as a result of a syrinx or reflex sympathetic dystrophy;
- Pregnant women;
- Shoulder pain that a MWU describes as limiting their ability to propel a manual wheelchair;
- History of neurologic disorder other than spinal cord injury (e.g. brain injury).
- Inexperienced Manual Wheelchair Users:
Show all 10Show fewer
- History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
- Have a musculoskeletal disorder;
- Pregnant women;
- Shoulder pain that limits their ability to propel a manual wheelchair.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Medical Rehabilitation Research and Education Center
West Orange, New Jersey, 07052
Sarah R. Dubowsky, Ph.D., 973-243-6838, sdubowsky@kmrrec.org
Andrew M. Kwarciak, M.S., 973-243-6903, akwarciak@kmrrec.org
About this study
Official title: Computationally Quantifying Wheelchair Set-Up to Minimize Peak Shoulder Joint Forces Throughout Manual Wheelchair Propulsion: A Pilot Study
Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion.
The purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). The primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs.
The hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). The overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.
- Conditions
- Paraplegia, Upper Limb Pain
- Keywords
- Wheelchair Set-Up, Shoulder Joint Forces, Manual Wheelchair Users, Paraplegia, Upper Limb Pain, Secondary Injury to Spinal Cord Injury, Biomechanics
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Able-bodied participants: Able-bodied individuals will be asked to propel a wheelchair at a self-selected speed for a period of time during which data will be collected on their propulsion biomechanics. It is assumed, for the purpose of the study, that un-learned able-bodied individuals learning to propel a wheelchair reflect newly injured individuals who are just getting accustomed to a new chair. | |
| 2 | Participants with paraplegia: Individuals who are at least 1-year post injury and have used a manual wheelchair as their primary means of locomotion during this time, will be assumed to be, for the purpose of this study, experienced wheelchair users. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak shoulder joint forces
Measured: During the propulsive phase of the push stroke at the time of data collection
Secondary outcomes (2)
Propulsion Speed
Measured: Measured during the data collection process
Horizontal and Vertical Axle Placement
Measured: Measured prior to data collection on each test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2009 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaplegiaStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Sarah R. Dubowsky, Ph.D., Principal investigator, Kessler Medical Rehabilitation Research and Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785278
- Sponsor's protocol ID
- R-619-08
- Status last verified
- Nov 2008
- First submitted
- 4 Nov 2008
- Last updated
- 5 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computationally Quantifying Wheelchair Set-Up to Minimize Peak Shoulder Joint Forces Throughout Manual Wheelchair Propulsion: A Pilot Study
- ClinicalTrials.gov ID
- NCT00785278
- Acronym / sponsor ID
- R-619-08
- Conditions
- Paraplegia, Upper Limb Pain
- Keywords
- Wheelchair Set-Up, Shoulder Joint Forces, Manual Wheelchair Users, Paraplegia, Upper Limb Pain, Secondary Injury to Spinal Cord Injury, Biomechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion.
The purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). The primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs.
The hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). The overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Able-bodied participants: Able-bodied individuals will be asked to propel a wheelchair at a self-selected speed for a period of time during which data will be collected on their propulsion biomechanics. It is assumed, for the purpose of the study, that un-learned able-bodied individuals learning to propel a wheelchair reflect newly injured individuals who are just getting accustomed to a new chair. |
| 2 | – | –Participants with paraplegia: Individuals who are at least 1-year post injury and have used a manual wheelchair as their primary means of locomotion during this time, will be assumed to be, for the purpose of this study, experienced wheelchair users. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of Northern New Jersey and the surrounding area and/or the patient population of the Kessler Medical Rehabilitation Research and Education Center (KMRREC). Subjects will be recruited from database search and word of mouth.
Key inclusion criteria (6 listed)
- Have a neurological impairment secondary to a spinal cord injury which occurred over 1 year prior to the start of the study;
- SCI at or below T1 (complete or incomplete);
- Use a manual wheelchair as a primary means of mobility (at least 40 hrs. per week but not necessarily always in motion);
- SCI after age 18
- Have 24 inch diameter wheels with quick-release axles.
Key exclusion criteria (10 listed)
- History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
- Upper limb dysthetic pain as a result of a syrinx or reflex sympathetic dystrophy;
- Pregnant women;
- Shoulder pain that a MWU describes as limiting their ability to propel a manual wheelchair;
- History of neurologic disorder other than spinal cord injury (e.g. brain injury).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak shoulder joint forces
Time frame: During the propulsive phase of the push stroke at the time of data collection
2 secondary outcomes
Propulsion Speed
Time frame: Measured during the data collection process
Horizontal and Vertical Axle Placement
Time frame: Measured prior to data collection on each test day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2008.
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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.
Sarah R. Dubowsky, Ph.D. principal investigator
Kessler Medical Rehabilitation Research and Education Center
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 Paraplegia and Upper Limb Pain, run by Kessler Foundation 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Nov 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah R. Dubowsky, Ph.D. (973-243-6838, sdubowsky@kmrrec.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak shoulder joint forces (time frame: During the propulsive phase of the push stroke at the time of data collection). 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 5 Nov 2008.