Spinal Cord InjuryPhase 2NCT00392860
Development of an Ergonomic Wheelchair Pushrim
A Phase 2 study testing Natural-Fit and PalmRim in people with Spinal Cord Injury, run by VA Pittsburgh Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Natural-Fit and PalmRim
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 2011
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
- Use a standard handrim
- Between the ages of 18 and 55
- Has normal hand function
- Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
- Use a vinyl-coated handrim
- Between ages 18 and 55
- Has impaired hand function
Who cannot join
- Pressure Sores
- PalmRim
- Pressure sores
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Development of an Ergonomic Manual Wheelchair Pushrim- Phase II
The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
Read the detailed description
This research will have three parts.
The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.
For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.
In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.
- Conditions
- Spinal Cord Injury
- Being tested
- Natural-Fit, PalmRim, Handrim Control Group
- Keywords
- Wheelchair, Handrims, Rehabilitation, Upper extremity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural-FitDevice
Ergonomic handrim for wheelchairs
PalmRimDevice
Ergonomic handrim for wheelchair
Handrim Control GroupDevice
Participants were given a new standard handrim to test. This intervention group is the control group.
| Study group | Role | What they receive |
|---|---|---|
| PalmRim Experimental | Experimental | Participants will have PalmRim installed on their wheelchair. Receives: Device: PalmRim |
| Natural-Fix Experiment | Experimental | Participants will have a Natural-Fit installed on their wheelchair. Receives: Device: Natural-Fit |
| Handrim Control | Placebo comparator | Participants in this arm had a new standard handrim installed on their wheelchair as a control. Receives: Device: Handrim Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Status Score
The Functional Status Scale, which measures hand and wrist symptoms.
Measured: Baseline, 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionSep 2011
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pittsburgh Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Michael Boninger, University of Pittsburgh
- Investigators
- Michael L Boninger, MD, Principal investigator, University of Pittsburgh and VA Pittsburgh Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392860
- Sponsor's protocol ID
- 02484, 0511136
- Status last verified
- Jan 2014
- First submitted
- 24 Oct 2006
- Last updated
- 21 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Ergonomic Manual Wheelchair Pushrim- Phase II
- ClinicalTrials.gov ID
- NCT00392860
- Acronym / sponsor ID
- 02484, 0511136
- Conditions
- Spinal Cord Injury
- Keywords
- Wheelchair, Handrims, Rehabilitation, Upper extremity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Collaborators
- University of Pittsburgh
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Posted 21 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
Detailed description
This research will have three parts.
The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.
For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.
In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PalmRim Experimental | Experimental | Device: PalmRimParticipants will have PalmRim installed on their wheelchair. |
| Natural-Fix Experiment | Experimental | Device: Natural-FitParticipants will have a Natural-Fit installed on their wheelchair. |
| Handrim Control | Placebo comparator | Device: Handrim Control GroupParticipants in this arm had a new standard handrim installed on their wheelchair as a control. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
- Use a standard handrim
- Between the ages of 18 and 55
- Has normal hand function
- Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
Key exclusion criteria (3 listed)
- Pressure Sores
- PalmRim
- Pressure sores
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 |
|---|---|---|
| Natural-FitErgonomic handrim for wheelchairs | Device | Natural-Fix Experiment |
| PalmRimErgonomic handrim for wheelchair | Device | PalmRim Experimental |
| Handrim Control GroupParticipants were given a new standard handrim to test. This intervention group is the control group. | Device | Handrim Control |
Primary outcome
Change in Functional Status Score
Time frame: Baseline, 4 Months
The Functional Status Scale, which measures hand and wrist symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael L Boninger, MD principal investigator
University of Pittsburgh and VA Pittsburgh Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Natural-Fit and PalmRim in people with Spinal Cord Injury, run by VA Pittsburgh Healthcare System 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 8 inclusion and 3 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 21 Feb 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2014). 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?
Change in Functional Status Score (time frame: Baseline, 4 Months). 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 21 Feb 2014.