Spinal Cord InjuriesNCT03781609
Motor Learning Approach for Manual Wheelchair Users
A study testing Roller system group (RG) and Overground group (OG) in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overall purpose of this project is to pilot test a manual wheelchair (MWC) training program based on motor learning theory to improve wheelchair propulsion for manual wheelchair users (MWUs) with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Roller system group (RG) and Overground group (OG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 30 Jul 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be 18 to 60 years of age
- Have a mobility limitation due to SCI, which requires the use of a manual wheelchair (MWC)
- Be able to self-propel a MWC bilaterally with their upper extremities
- Plan to use a MWC for at least 75% of activities throughout the day
- Live in the community
- Understand English at a sixth-grade level or higher
Show all 10Show fewer
- Be able to follow multi-step instructions
- Participants must be able to provide informed consent independently
- Be able to tolerate propelling their wheelchair independently for 10 meters
- Be willing to participate in three assessments and up to 13 training sessions at the Enabling Mobility in the Community Laboratory (EMC Lab).
Who cannot join
- People will be excluded if they maneuver their MWC with their lower extremities or with only one upper extremity.
- Individuals who display the proper MWC propulsion techniques during the screening process, who already follow the CPG, or whose MWC position inhibits them from following the CPG will be excluded.
- Potential participants also will be excluded if they have bilateral incoordination due to strength inequality or neurological involvement that impairs propulsion in a steady, straight line. Specifically, if a person demonstrates upper extremity strength inequalities resulting in a 12-inch deviation from a marked pathway, he or she will be excluded.
- Other exclusionary criteria include surgeries compromising the integrity of the upper extremities or cardiovascular complications within the past year.
- Potential participants will also be excluded if upper extremity or overall bodily pain is rated 8/10 or higher per the Wong-Baker FACES Numeric Pain Scale (FACES). -In addition, potential participants will be excluded if they are currently receiving medical treatment for an acute upper extremity injury, have a Stage IV pressure injury, or are currently hospitalized.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: A Motor Learning Approach to Wheelchair Propulsion Training for Manual Wheelchair Users With SCI
The overall purpose of this project is to pilot test a manual wheelchair (MWC) training program based on motor learning theory to improve wheelchair propulsion for manual wheelchair users (MWUs) with spinal cord injury (SCI).
Read the detailed description
The project objective is to conduct a pilot randomized control trial (RCT) examining (1) the number of task-specific repetitions required to produce change in wheelchair propulsion techniques and (2) identifying the most conducive surface (overground or on a stationary device such as rollers) for implementing a repetition-based manual wheelchair propulsion training program. The long-term goals of this research are to minimize upper extremity pain and chronic overuse injury and to increase mobility efficiency in in persons with SCI who use MWCs for everyday mobility. The current project goal is to test the effects of a repetition-based manual wheelchair propulsion training program that emphasizes the recommended clinical practice guidelines (CPG). The expected outcome will be evidence to use in training MWUs with SCI in proper propulsion techniques in order to prevent or delay pain and chronic overuse injuries and maximize mobility through efficient wheelchair propulsion techniques. The long-term impact will be implementing evidence-based MWC propulsion training in appropriate amounts to facilitate a reduction in pain and dysfunction, a reduction in health costs, and prolonged participation in major life activities for MWUs with SCI.
Our research aims are to:
- Compare wheelchair propulsion kinematics, kinetics, and wheelchair performance changes among three independent groups (Roller Group, Overground Group, Wheelchair Skills Group).
- Characterize the dose-response relationship of repetition-based propulsion practice.
- Evaluate the long-term impact of propulsion training on performance in the lived environment.
A single-blind pilot RCT will be conducted. Forty-eight individuals with SCI who use MWCs and who do not follow the recommended clinical guidelines for propulsion will be recruited. Each participant will be randomized into one of three independent groups: motor learning repetitions on a roller system (RG), motor learning repetitions overground (OG), or the placebo-controlled group receiving conventional MWC skills training (WSG). The WSG will operate as a placebo by receiving basic MWC skills training-the current standard of rehabilitation care. Participants' kinematics (video motion analysis), kinetics (SmartWheel), and wheelchair performance overground (Wheelchair Propulsion Test) will be assessed pre-intervention (Baseline), immediately following intervention (Follow-up), and three months' post-intervention (3-Month Follow-up).
- Conditions
- Spinal Cord Injuries
- Being tested
- Roller system group (RG), Overground group (OG), Placebo - Wheelchair skills group (WSG)
- Keywords
- manual wheelchair, wheelchair propulsion, occupational therapy, motor learning
- 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.
Roller system group (RG)Behavioural
They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions on the roller system per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.
Overground group (OG)Behavioural
They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions overground per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.
Placebo - Wheelchair skills group (WSG)Behavioural
They will receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented.
| Study group | Role | What they receive |
|---|---|---|
| Roller system group (RG) | Active comparator | A group performing motor learning manual wheelchair propulsion repetitions on a roller system. Receives: Behavioral: Roller system group (RG) |
| Overground group (OG) | Active comparator | A group performing motor learning manual wheelchair propulsion repetitions overground. Receives: Behavioral: Overground group (OG) |
| Placebo - Wheelchair skills group (WSG) | Placebo comparator | A group receiving conventional manual wheelchair skills training. Receives: Behavioral: Placebo - Wheelchair skills group (WSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video Motion Capture-Hand Axle relationship Change
Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Hand-axle relationship will be measured in centimeters and compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (bringing the hand down toward the axle during recovery [hand-axle relationship].
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Video Motion Capture-Push Angle Change
Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Push angle will be compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (use longer push strokes [push angle].
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Wheelchair Propulsion Test (WPT)-Number of pushes Change
The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The number of pushes needed to complete the 10 meters,will all noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Wheelchair Propulsion Test (WPT)-time to complete 10 meter push Change
The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. Observation of the participant's propulsion pattern as well as whether their hands make contact with the pushrims, recovery, time to complete the 10 meters will be collected. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Wheelchair Propulsion Test (WPT)-type of propulsion pattern comparison between time points
The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The participant's dominant propulsion pattern will be noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Secondary outcomes (4)
Outdoor Propulsion Test-Total push count
Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Total propulsion counts will be recorded and compared within and between subjects.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Outdoor Propulsion Test-# of pushes meeting clinical guidelines
Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Propulsion counts will be recorded and compared within and between subjects.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Outdoor Propulsion Test-Type of propulsion pattern
Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Propulsion patterns will be recorded and compared within and between subjects.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Outdoor Propulsion Test-Time to complete route
Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Time to complete the route will be recorded and compared within and between subjects.
Measured: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start5 Nov 2018
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (125)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Sponsor
- Investigators
- Kerri A Morgan, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781609
- Sponsor's protocol ID
- 201804133
- Status last verified
- Oct 2021
- First submitted
- 21 Nov 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
National Spinal Cord Injury Statistical Center. (2016). Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham.
Cott CA. Client-centred rehabilitation: client perspectives. Disabil Rehabil. 2004 Dec 16;26(24):1411-22. doi: 10.1080/09638280400000237.
PubMed 15764361Morgan KA, Engsberg JR, Gray DB. Important wheelchair skills for new manual wheelchair users: health care professional and wheelchair user perspectives. Disabil Rehabil Assist Technol. 2017 Jan;12(1):28-38. doi: 10.3109/17483107.2015.1063015. Epub 2015 Jul 3.
PubMed 26138222Cox RJ, Amsters DI, Pershouse KJ. The need for a multidisciplinary outreach service for people with spinal cord injury living in the community. Clin Rehabil. 2001 Dec;15(6):600-6. doi: 10.1191/0269215501cr453oa.
PubMed 11777090Estores IM. The consumer's perspective and the professional literature: what do persons with spinal cord injury want? J Rehabil Res Dev. 2003 Jul-Aug;40(4 Suppl 1):93-8. doi: 10.1682/jrrd.2003.08.0093.
PubMed 15077653National Spinal Cord Injury Statistical Center. (2015). Annual Statistical Report-Complete Public Version. Birmingham, AL: University of Alabama at Birmingham.
Kaye, H. S., Kang, T., & LaPlante, M. P. (2002). Wheelchair use in the United States [abstract]. Disability Statistics Abstract, 23, 1-4.
LaPlante MP, Kaye HS. Demographics and trends in wheeled mobility equipment use and accessibility in the community. Assist Technol. 2010 Spring;22(1):3-17; quiz 19. doi: 10.1080/10400430903501413.
PubMed 20402043Kilkens OJ, Dallmeijer AJ, De Witte LP, Van Der Woude LH, Post MW. The Wheelchair Circuit: Construct validity and responsiveness of a test to assess manual wheelchair mobility in persons with spinal cord injury. Arch Phys Med Rehabil. 2004 Mar;85(3):424-31. doi: 10.1016/j.apmr.2003.05.006.
PubMed 15031828Kilkens OJ, Post MW, Dallmeijer AJ, van Asbeck FW, van der Woude LH. Relationship between manual wheelchair skill performance and participation of persons with spinal cord injuries 1 year after discharge from inpatient rehabilitation. J Rehabil Res Dev. 2005 May-Jun;42(3 Suppl 1):65-73. doi: 10.1682/jrrd.2004.08.0093.
PubMed 16195964Ozturk A, Ucsular FD. Effectiveness of a wheelchair skills training programme for community-living users of manual wheelchairs in Turkey: a randomized controlled trial. Clin Rehabil. 2011 May;25(5):416-24. doi: 10.1177/0269215510386979. Epub 2010 Nov 8.
PubMed 21059666Bernard, B. P., Cohen, A. L., Fine, L. J., Gjessing, C. C., & McGlothlin, J. D. (1997). Elements of ergonomics programs: A primer based on workplace evaluations of musculoskeletal disorders. US Department of Health and Human Services publication, (97-117).
Kohn, J. P. (1998). Ergonomics Process Management: A Blueprint for Quality and Compliance. Boca Raton, FL: CRC Press.
Boninger ML, Cooper RA, Robertson RN, Rudy TE. Wrist biomechanics during two speeds of wheelchair propulsion: an analysis using a local coordinate system. Arch Phys Med Rehabil. 1997 Apr;78(4):364-72. doi: 10.1016/s0003-9993(97)90227-6.
PubMed 9111455Hoover, A. E., Cooper, R. A., Dan, D., Dvorsnak, M., Cooper, R., Fitzgerald, S. G., & Boninger, M. L. (2003). Comparing driving habits of wheelchair users: Manual versus power. In Proceedings of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) 26th International Conference on Technology & Disability: Research, Design, Practice, and Policy, (pp. 19-23).
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Motor Learning Approach to Wheelchair Propulsion Training for Manual Wheelchair Users With SCI
- ClinicalTrials.gov ID
- NCT03781609
- Acronym / sponsor ID
- 201804133
- Conditions
- Spinal Cord Injuries
- Keywords
- manual wheelchair, wheelchair propulsion, occupational therapy, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- 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 overall purpose of this project is to pilot test a manual wheelchair (MWC) training program based on motor learning theory to improve wheelchair propulsion for manual wheelchair users (MWUs) with spinal cord injury (SCI).
Detailed description
The project objective is to conduct a pilot randomized control trial (RCT) examining (1) the number of task-specific repetitions required to produce change in wheelchair propulsion techniques and (2) identifying the most conducive surface (overground or on a stationary device such as rollers) for implementing a repetition-based manual wheelchair propulsion training program. The long-term goals of this research are to minimize upper extremity pain and chronic overuse injury and to increase mobility efficiency in in persons with SCI who use MWCs for everyday mobility. The current project goal is to test the effects of a repetition-based manual wheelchair propulsion training program that emphasizes the recommended clinical practice guidelines (CPG). The expected outcome will be evidence to use in training MWUs with SCI in proper propulsion techniques in order to prevent or delay pain and chronic overuse injuries and maximize mobility through efficient wheelchair propulsion techniques. The long-term impact will be implementing evidence-based MWC propulsion training in appropriate amounts to facilitate a reduction in pain and dysfunction, a reduction in health costs, and prolonged participation in major life activities for MWUs with SCI.
Our research aims are to:
- Compare wheelchair propulsion kinematics, kinetics, and wheelchair performance changes among three independent groups (Roller Group, Overground Group, Wheelchair Skills Group).
- Characterize the dose-response relationship of repetition-based propulsion practice.
- Evaluate the long-term impact of propulsion training on performance in the lived environment.
A single-blind pilot RCT will be conducted. Forty-eight individuals with SCI who use MWCs and who do not follow the recommended clinical guidelines for propulsion will be recruited. Each participant will be randomized into one of three independent groups: motor learning repetitions on a roller system (RG), motor learning repetitions overground (OG), or the placebo-controlled group receiving conventional MWC skills training (WSG). The WSG will operate as a placebo by receiving basic MWC skills training-the current standard of rehabilitation care. Participants' kinematics (video motion analysis), kinetics (SmartWheel), and wheelchair performance overground (Wheelchair Propulsion Test) will be assessed pre-intervention (Baseline), immediately following intervention (Follow-up), and three months' post-intervention (3-Month Follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roller system group (RG) | Active comparator | Behavioral: Roller system group (RG)A group performing motor learning manual wheelchair propulsion repetitions on a roller system. |
| Overground group (OG) | Active comparator | Behavioral: Overground group (OG)A group performing motor learning manual wheelchair propulsion repetitions overground. |
| Placebo - Wheelchair skills group (WSG) | Placebo comparator | Behavioral: Placebo - Wheelchair skills group (WSG)A group receiving conventional manual wheelchair skills training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants must be 18 to 60 years of age
- Have a mobility limitation due to SCI, which requires the use of a manual wheelchair (MWC)
- Be able to self-propel a MWC bilaterally with their upper extremities
- Plan to use a MWC for at least 75% of activities throughout the day
- Live in the community
Key exclusion criteria (5 listed)
- People will be excluded if they maneuver their MWC with their lower extremities or with only one upper extremity.
- Individuals who display the proper MWC propulsion techniques during the screening process, who already follow the CPG, or whose MWC position inhibits them from following the CPG will be excluded.
- Potential participants also will be excluded if they have bilateral incoordination due to strength inequality or neurological involvement that impairs propulsion in a steady, straight line. Specifically, if a person demonstrates upper extremity strength inequalities resulting in a 12-inch deviation from a marked pathway, he or she will be excluded.
- Other exclusionary criteria include surgeries compromising the integrity of the upper extremities or cardiovascular complications within the past year.
- Potential participants will also be excluded if upper extremity or overall bodily pain is rated 8/10 or higher per the Wong-Baker FACES Numeric Pain Scale (FACES). -In addition, potential participants will be excluded if they are currently receiving medical treatment for an acute upper extremity injury, have a Stage IV pressure injury, or are currently hospitalized.
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 |
|---|---|---|
| Roller system group (RG)They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions on the roller system per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion. | Behavioural | Roller system group (RG) |
| Overground group (OG)They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions overground per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion. | Behavioural | Overground group (OG) |
| Placebo - Wheelchair skills group (WSG)They will receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. | Behavioural | Placebo - Wheelchair skills group (WSG) |
Primary outcome
Video Motion Capture-Hand Axle relationship Change
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Hand-axle relationship will be measured in centimeters and compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (bringing the hand down toward the axle during recovery [hand-axle relationship].
Video Motion Capture-Push Angle Change
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Push angle will be compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (use longer push strokes [push angle].
Wheelchair Propulsion Test (WPT)-Number of pushes Change
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The number of pushes needed to complete the 10 meters,will all noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
Wheelchair Propulsion Test (WPT)-time to complete 10 meter push Change
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. Observation of the participant's propulsion pattern as well as whether their hands make contact with the pushrims, recovery, time to complete the 10 meters will be collected. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
Wheelchair Propulsion Test (WPT)-type of propulsion pattern comparison between time points
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The participant's dominant propulsion pattern will be noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
4 secondary outcomes
Outdoor Propulsion Test-Total push count
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Outdoor Propulsion Test-# of pushes meeting clinical guidelines
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Outdoor Propulsion Test-Type of propulsion pattern
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Outdoor Propulsion Test-Time to complete route
Time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
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 6 Oct 2021.
- BackgroundNational Spinal Cord Injury Statistical Center. (2016). Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham.
- Background: PubMed 15764361Cott CA. Client-centred rehabilitation: client perspectives. Disabil Rehabil. 2004 Dec 16;26(24):1411-22. doi: 10.1080/09638280400000237.
- Background: PubMed 26138222Morgan KA, Engsberg JR, Gray DB. Important wheelchair skills for new manual wheelchair users: health care professional and wheelchair user perspectives. Disabil Rehabil Assist Technol. 2017 Jan;12(1):28-38. doi: 10.3109/17483107.2015.1063015. Epub 2015 Jul 3.
- Background: PubMed 11777090Cox RJ, Amsters DI, Pershouse KJ. The need for a multidisciplinary outreach service for people with spinal cord injury living in the community. Clin Rehabil. 2001 Dec;15(6):600-6. doi: 10.1191/0269215501cr453oa.
- Background: PubMed 15077653Estores IM. The consumer's perspective and the professional literature: what do persons with spinal cord injury want? J Rehabil Res Dev. 2003 Jul-Aug;40(4 Suppl 1):93-8. doi: 10.1682/jrrd.2003.08.0093.
- BackgroundNational Spinal Cord Injury Statistical Center. (2015). Annual Statistical Report-Complete Public Version. Birmingham, AL: University of Alabama at Birmingham.
- BackgroundKaye, H. S., Kang, T., & LaPlante, M. P. (2002). Wheelchair use in the United States [abstract]. Disability Statistics Abstract, 23, 1-4.
- Background: PubMed 20402043LaPlante MP, Kaye HS. Demographics and trends in wheeled mobility equipment use and accessibility in the community. Assist Technol. 2010 Spring;22(1):3-17; quiz 19. doi: 10.1080/10400430903501413.
- Background: PubMed 15031828Kilkens OJ, Dallmeijer AJ, De Witte LP, Van Der Woude LH, Post MW. The Wheelchair Circuit: Construct validity and responsiveness of a test to assess manual wheelchair mobility in persons with spinal cord injury. Arch Phys Med Rehabil. 2004 Mar;85(3):424-31. doi: 10.1016/j.apmr.2003.05.006.
- Background: PubMed 16195964Kilkens OJ, Post MW, Dallmeijer AJ, van Asbeck FW, van der Woude LH. Relationship between manual wheelchair skill performance and participation of persons with spinal cord injuries 1 year after discharge from inpatient rehabilitation. J Rehabil Res Dev. 2005 May-Jun;42(3 Suppl 1):65-73. doi: 10.1682/jrrd.2004.08.0093.
- Background: PubMed 21059666Ozturk A, Ucsular FD. Effectiveness of a wheelchair skills training programme for community-living users of manual wheelchairs in Turkey: a randomized controlled trial. Clin Rehabil. 2011 May;25(5):416-24. doi: 10.1177/0269215510386979. Epub 2010 Nov 8.
- BackgroundBernard, B. P., Cohen, A. L., Fine, L. J., Gjessing, C. C., & McGlothlin, J. D. (1997). Elements of ergonomics programs: A primer based on workplace evaluations of musculoskeletal disorders. US Department of Health and Human Services publication, (97-117).
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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.
Kerri A Morgan, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roller system group (RG) and Overground group (OG) in people with Spinal Cord Injuries, run by Washington University School of Medicine 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 5 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 6 Oct 2021. 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.
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?
Video Motion Capture-Hand Axle relationship Change (time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781609, which also lists 125 linked publications.
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 6 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.