Manual Wheelchair UsersNCT00226252
Manual Wheelchair Propulsion Training
A study testing Instruction Only and Instruction and Feedback in people with Manual Wheelchair Users, run by VA Pittsburgh Healthcare System at 1 site in United States.
Trial summary
The purpose of this research study is to investigate a manual wheelchair training program to improve the way manual wheelchair users push their wheelchairs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Manual Wheelchair Users
- What is being tested?
- Instruction Only and Instruction and Feedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Nov 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or greater
- Use of a manual wheelchair as primary means of mobility (>80% of their ambulation)
- Spinal Cord Injury (SCI) cervical 7 level and lower
Who cannot join
- Wheelchair athletes having competed in racing in the last year.
- Current upper limb pain that limits mobility.
- <1 year post inpatient rehabilitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, 15206
About this study
The purpose of this research study is to investigate a manual wheelchair training program to improve the way manual wheelchair users push their wheelchairs.
Read the detailed description
The purpose of this research is to create a manual wheelchair propulsion-training program (MWPTP) that emphasizes propulsion techniques that improve the manual wheelchair users stroke pattern and efficiency. It is our hope that the design of a manual wheelchair-training program can help to minimize the upper extremity pain and injury often associated with manual wheelchair propulsion.
The MWPTP will exist in three forms, and will be given to three randomly assigned groups of subjects. An instruction only group (IO) will receive general instructions on how to best propel their wheelchair. A feedback group (FB) will receive additional instruction in wheelchair propulsion using a monitor displaying a random combination and amount of biomechanical feedback variables, such as cadence and proportion of time spent in propulsion. Subjects will be coached to develop an appropriate propulsion style that minimizes all of the predetermined feedback measures, which indicate poor technique and maximize all of the graphical measures indicating good propulsion technique. A control group (CG) will receive only testing which will be identical to the testing procedures followed by the IO and FB groups.
Participation in this study will consist of four visits to the Human Engineering Research Lab (HERL) for the FB, IO and CG. Visits 1-4 will be the same, except visit 4 will not include training for any of the groups. All subjects will use their own wheelchair and cushion; however researchers will attach SMART Wheels TM to the subjects' wheelchair in place of their current wheels. The SMART Wheels TM are used to record the forces and moments that occur during propulsion and will not alter the dimensions or feel of the subjects current wheelchair. During each visit, all subjects will be asked to push over a real life course that includes various grades and surfaces. Then they will be asked to push on a wheelchair dynamometer at 1 meter/sec for one minute, 2 meter/sec for one minute, and a self selected speed for one minute. During this time, data will may also be collected with use of an Optotrak kinematic measurement system that incorporates a camera 3D-motion analysis system.
- Conditions
- Manual Wheelchair Users
- Being tested
- Instruction Only, Instruction and Feedback
- Keywords
- Wheelchair, Propulsion, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction OnlyProcedure or surgery
Video details an individual propelling a manual wheelchair with biomechanically correct propulsion technique.
Instruction and FeedbackProcedure or surgery
Individuals will watch video of correct propulsion technique and will receive real-time feedback from the SMART Wheel as they push their wheelchair to help optimize their propulsion technique.
| Study group | Role | What they receive |
|---|---|---|
| Instruction Only (IO) | Experimental | IO participants will train on the dynamometer for the same length of time as the Feedback Group. They will only be instructed to follow what they learned from the video presented at the beginning of the training session. Receives: Procedure: Instruction Only |
| Instruction and Feedback Group (FB) | Experimental | The FB group will receive video training, and real time feedback from the SMART Wheel as they push their wheelchair. A monitor displaying a random combination and amount of biomechanical feedback variables will be placed in front of subjects. Subjects will be instructed to adjust their stroke to optimize their biomechanics with feedback from the screen. Receives: Procedure: Instruction and Feedback |
| Control Group | No intervention | Wheelchair characteristics will be noted; however, no wheelchair manipulation or changes in equipment will be performed or recommended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke frequency, peak forces, time spent in propulsion
Measured: initial visit, visit 2 (1 week later), visit 3 (2 weeks later), visit 4 (3 months from initial visit)
Stroke pattern
Measured: initial visit, visit 2 (1 week later), visit 3 (2 weeks later), and visit 4 (3 months from initial visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionMar 2008
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual Wheelchair UsersStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT00226252
- Sponsor's protocol ID
- 02159
- Status last verified
- Mar 2013
- First submitted
- 22 Sep 2005
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Wheelchair Propulsion Training
- ClinicalTrials.gov ID
- NCT00226252
- Acronym / sponsor ID
- 02159
- Conditions
- Manual Wheelchair Users
- Keywords
- Wheelchair, Propulsion, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Collaborators
- University of Pittsburgh
- Study start
- Dec 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Sep 2005 (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.
The purpose of this research study is to investigate a manual wheelchair training program to improve the way manual wheelchair users push their wheelchairs.
Detailed description
The purpose of this research is to create a manual wheelchair propulsion-training program (MWPTP) that emphasizes propulsion techniques that improve the manual wheelchair users stroke pattern and efficiency. It is our hope that the design of a manual wheelchair-training program can help to minimize the upper extremity pain and injury often associated with manual wheelchair propulsion.
The MWPTP will exist in three forms, and will be given to three randomly assigned groups of subjects. An instruction only group (IO) will receive general instructions on how to best propel their wheelchair. A feedback group (FB) will receive additional instruction in wheelchair propulsion using a monitor displaying a random combination and amount of biomechanical feedback variables, such as cadence and proportion of time spent in propulsion. Subjects will be coached to develop an appropriate propulsion style that minimizes all of the predetermined feedback measures, which indicate poor technique and maximize all of the graphical measures indicating good propulsion technique. A control group (CG) will receive only testing which will be identical to the testing procedures followed by the IO and FB groups.
Participation in this study will consist of four visits to the Human Engineering Research Lab (HERL) for the FB, IO and CG. Visits 1-4 will be the same, except visit 4 will not include training for any of the groups. All subjects will use their own wheelchair and cushion; however researchers will attach SMART Wheels TM to the subjects' wheelchair in place of their current wheels. The SMART Wheels TM are used to record the forces and moments that occur during propulsion and will not alter the dimensions or feel of the subjects current wheelchair. During each visit, all subjects will be asked to push over a real life course that includes various grades and surfaces. Then they will be asked to push on a wheelchair dynamometer at 1 meter/sec for one minute, 2 meter/sec for one minute, and a self selected speed for one minute. During this time, data will may also be collected with use of an Optotrak kinematic measurement system that incorporates a camera 3D-motion analysis system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instruction Only (IO) | Experimental | Procedure: Instruction OnlyIO participants will train on the dynamometer for the same length of time as the Feedback Group. They will only be instructed to follow what they learned from the video presented at the beginning of the training session. |
| Instruction and Feedback Group (FB) | Experimental | Procedure: Instruction and FeedbackThe FB group will receive video training, and real time feedback from the SMART Wheel as they push their wheelchair. A monitor displaying a random combination and amount of biomechanical feedback variables will be placed in front of subjects. Subjects will be instructed to adjust their stroke to optimize their biomechanics with feedback from the screen. |
| Control Group | No intervention | –Wheelchair characteristics will be noted; however, no wheelchair manipulation or changes in equipment will be performed or recommended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or greater
- Use of a manual wheelchair as primary means of mobility (>80% of their ambulation)
- Spinal Cord Injury (SCI) cervical 7 level and lower
Key exclusion criteria (3 listed)
- Wheelchair athletes having competed in racing in the last year.
- Current upper limb pain that limits mobility.
- <1 year post inpatient rehabilitation
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 |
|---|---|---|
| Instruction OnlyVideo details an individual propelling a manual wheelchair with biomechanically correct propulsion technique. | Procedure or surgery | Instruction Only (IO) |
| Instruction and FeedbackIndividuals will watch video of correct propulsion technique and will receive real-time feedback from the SMART Wheel as they push their wheelchair to help optimize their propulsion technique. | Procedure or surgery | Instruction and Feedback Group (FB) |
Primary outcome
Stroke frequency, peak forces, time spent in propulsion
Time frame: initial visit, visit 2 (1 week later), visit 3 (2 weeks later), visit 4 (3 months from initial visit)
Stroke pattern
Time frame: initial visit, visit 2 (1 week later), visit 3 (2 weeks later), and visit 4 (3 months from initial visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
Related trials for Manual Wheelchair Users
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Shoulder Health After Rehabilitation and Performance Training
Spinal Cord Injury, Nervous System Diseases
Not yet recruitingObservational study
New Rear Anti-tip Device for Manual Wheelchairs: Subjective Input (RAD-SI)
Wheelchair Users, Caregivers
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 study testing Instruction Only and Instruction and Feedback in people with Manual Wheelchair Users, 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 3 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 12 Mar 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stroke frequency, peak forces, time spent in propulsion (time frame: initial visit, visit 2 (1 week later), visit 3 (2 weeks later), visit 4 (3 months from initial visit)). The study lists 2 primary outcomes in all. 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 12 Mar 2013.