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Motor Learning Approach for Manual Wheelchair Users

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ClinicalTrials.gov Identifier: NCT03781609
Recruitment Status : Suspended (Temporarily paused due to COVID-19, expected to resume, IRB not suspended.)
First Posted : December 20, 2018
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Roller system group (RG) Behavioral: Overground group (OG) Behavioral: Placebo - Wheelchair skills group (WSG) Not Applicable

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:

  1. Compare wheelchair propulsion kinematics, kinetics, and wheelchair performance changes among three independent groups (Roller Group, Overground Group, Wheelchair Skills Group).
  2. Characterize the dose-response relationship of repetition-based propulsion practice.
  3. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Motor Learning Approach to Wheelchair Propulsion Training for Manual Wheelchair Users With SCI
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Roller system group (RG)
A group performing motor learning manual wheelchair propulsion repetitions on a roller system.
Behavioral: 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.

Active Comparator: Overground group (OG)
A group performing motor learning manual wheelchair propulsion repetitions overground.
Behavioral: 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.

Placebo Comparator: Placebo - Wheelchair skills group (WSG)
A group receiving conventional manual wheelchair skills training.
Behavioral: 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.




Primary Outcome Measures :
  1. 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].

  2. 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].

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Outdoor Propulsion Test-Total push count [ Time Frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention ]
    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.

  2. Outdoor Propulsion Test-# of pushes meeting clinical guidelines [ Time Frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention ]
    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.

  3. Outdoor Propulsion Test-Type of propulsion pattern [ Time Frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention ]
    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.

  4. Outdoor Propulsion Test-Time to complete route [ Time Frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention ]
    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.


Other Outcome Measures:
  1. Wheelchair User's Shoulder Pain Index (WUSPI) [ Time Frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention ]
    A self-report measure of shoulder pain in manual wheelchair users (MWUs) during functional activities. The WUSPI consists of a 15-item questionnaire addressing shoulder pain during 15 activities within four domains: transfers, wheelchair mobility, self-care, and general activities. A 10-point visual analog scale ranging from 0 (no pain) to 10 (worst pain) is used to determine pain intensity experienced during each activity. The WUSPI score (from 0 [no pain] to 150 [worst pain] across all items) indicates the participant's level of shoulder pain during functional activities. Reliability and validity have been established by sampling long-term MWUs. The WUSPI has excellent test-retest reliability (ICC = .99),3 excellent internal consistency (α = .97),3 and moderate concurrent validity (r = -.49). Excellent convergent validity was established by correlating the WUSPI with pain intensity on a numeric rating scale (r = .77; p < .003).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781609


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
The Craig H. Neilsen Foundation
Investigators
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Principal Investigator: Kerri A Morgan, PhD Washington University School of Medicine
Publications:
National Spinal Cord Injury Statistical Center. (2016). Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham.
National 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.
Bernard, 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.
Hoover, 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).
Axelson, P., Chesney, D. Y., Minkel, J., & Perr, A. (1996). The manual wheelchair training guide. Santa Cruz, CA: Pax Press.
Isaacson, M. (2011). Best practices by occupational and physical therapists performing seating and mobility evaluations. Assistive Technology, 23(1), 13-21.
Mitchell, M., Jin, B. T., Kim, A. J., Giesbrecht, E. M., Miller, W. C. (2014). METTA: A tablet-based platform for monitored at-home training as demonstrated through the EPIC Wheels Wheelchair Skills Training Program. In Proceedings of the Rehabilitation Engineering and Assistive Technology Society of North America Conference. Vancouver: University of British Columbia.
Baddeley, A. D. & Longman, D. J. A. (1978). The influence of length and frequency of training session on the rate of learning to type. Ergonomics, 21(8), 627-635.
National Spinal Cord Injury Statistical Center. (2016). Spinal Cord Injury Data Sheet. Birmingham: University of Alabama at Birmingham.
Will, K., Engsberg, J. R., Foreman, M., Klaesner, J., Birkenmeier, R., & Morgan, K. A. (2015). Repetition based training for efficient propulsion in new manual wheelchair users. Journal of Physical Medicine, Rehabilitation & Disabilities, 1(001), 1-9.
SAS Institute Inc., Cary, NC, USA.
Motion Analysis Corporation. HiRes Motion Analysis Corporation System. Santa Rosa, CA.
Three Rivers Holdings, LLC. SmartWheel. Mesa, AZ.
ActiGraph, LLC. GT9X Activity Monitors. Pensacola, FL.
Shea, J. B. & Morgan, R. L. (1979). Contextual interference effects on the acquisition, retention, and transfer of a motor skill. Journal of Experimental Psychology: Human Learning and Memory, 5, 179-187.
MATLAB version 7.10.0. (2010). Natick, Massachusetts: The MathWorks Inc.
SPSS Inc. (2012). SPSS Statistics Version 21. Chicago, IL: IBM.

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03781609    
Other Study ID Numbers: 201804133
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
manual wheelchair
wheelchair propulsion
occupational therapy
motor learning
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries