- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009187
A Wheelchair Propulsion Training Program (HS)
Efficacy of a Wheelchair Propulsion Training Program for Manual Wheelchair Users: a Pilot Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this project is to develop a feasible wheelchair propulsion training that can fit into an in-patient rehabilitation schedule, and determine the effectiveness of the training protocol. This project consists of a randomized control trial (RCT) for manual wheelchair users (MWUs) that examines the number of manual wheelchair propulsion repetitions required to produce change. For the RCT, we will recruit twenty individuals who use manual wheelchairs as their primary means of mobility and who do not follow the recommended clinical guidelines for propulsion. Participants will be randomized into two independent groups: motor learning repetitions overground (Training Group; n =10), and general education on recommended propulsion techniques (Education Group; n =10). Demographics, cognition, shoulder strength, participation, and wheelchair seating may only be assessed at baseline. Participants then may be assessed from the kinematics of their wheelchair performance overground and on a motorized treadmill. Participants may be tested on their wheelchair propulsion techniques in and outside of the lab, upper extremity pain at baseline, post-intervention, and three-week follow-up; participants may also be asked qualitative questions regarding the intervention experience, the experience with the equipment and the laboratory research, the monitoring setting, and the general experience with the research study.
The primary research question is that will repetition of proper propulsion technique practiced overground result in improved manual wheelchair propulsion biomechanics?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63108
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-65 years of age
- have a mobility limitation requiring 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 their activities throughout the day
- live in the community
- understand English at a sixth-grade level or higher
- can follow multi-step instructions
- able to provide informed consent independently
- able to tolerate propelling their wheelchair independently for 10m
- be willing to participate in three assessments and six training sessions at the Enabling Mobility in the Community Laboratory (EMC Lab).
Exclusion Criteria:
- maneuver their MWC with their lower extremities or with only one upper extremity
- display the proper wheelchair propulsion techniques during the screening process
- MWC position inhibits them from following the CPGs
- bilateral incoordination
- upper extremity strength inequalities resulting in a 12-inch deviation from a marked pathway
- surgeries compromising the integrity of the upper extremities
- cardiovascular complications within the past year
- upper extremity or overall bodily pain is rated 8/10 or higher per the Wong-Baker FACES Numeric Pain Scale (FACES)
- currently receiving medical treatment for an acute upper extremity injury
- have a Stage IV pressure injury or are currently hospitalized
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Training group
Training group will first receive 30 minutes of education about biomechanically efficient propulsion techniques.
They will be tested on this knowledge to make sure participants understand the material.
The participant then will be asked to come into the lab for 6 sessions of training, two times per week for three weeks.
The training is an hour of the proper wheelchair propulsion techniques broken into 5 parts, 7 minutes each with breaks.
Based on the motor learning principles, we gradually increase the components of the training by focusing either hand reaching toward the back of the wheel or hands reaching down toward the axle.
|
The wheelchair propulsion (WP) intervention is based on our previous pilot work and the best available evidence on WP training.
The CPGs recommend minimizing the force and frequency of pushes while using long strokes during propulsion.
Each training session will include massed practice with repetitions overground.
Each session is organized to limit the number of variables (i.e., long push strokes and dropping the hands down below axle) presented to the participant at one time.
Propulsion Set A will focus on using longer push strokes.
Propulsion Set B will focus on dropping the hand down toward the axle.
Propulsion Set C will focus on both A and B.
Both groups will receive a 30-minute education session regarding the CPGs.
This education session will follow the instructions provided in Rice and colleagues.
(L. A. Rice et al., 2014).
It consists of the importance of practicing biomechanical efficient propulsion.
The material lists out the consequences and the impact of upper limb pain and injury.
It provides a detailed step by step on how to propel properly.
They will view the video that shows the biomechanics of efficient and inefficient propulsion.
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ACTIVE_COMPARATOR: Control group
Control group will first receive 30 minutes of education about the biomechanically efficient propulsion.
They will be tested on this knowledge to make sure participants understand the material.
No further training will be implemented with this group.
|
Both groups will receive a 30-minute education session regarding the CPGs.
This education session will follow the instructions provided in Rice and colleagues.
(L. A. Rice et al., 2014).
It consists of the importance of practicing biomechanical efficient propulsion.
The material lists out the consequences and the impact of upper limb pain and injury.
It provides a detailed step by step on how to propel properly.
They will view the video that shows the biomechanics of efficient and inefficient propulsion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motion capture - changes in push angle
Time Frame: Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
|
Push angle during the push phase of propulsion is assessed with video motion capture (VMC).
The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of the reflective markers, specifically on the shoulder, elbow, and wrist.
The 3D infrared coordinates will be recorded while participants propel their wheelchair over the ground and on a dynamic roller system.
Push angle will be calculated by finding the inner product of the vectors formed by the elbow-shoulder and elbow-wrist.
The push angles will be compared across the three testing sessions.
This variable corresponds to the recommendations outlined in the clinical practice guidelines.
We hypothesize that the increase of push angle will be greater in the training group than the control group.
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Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Motion capture - changes in hand-axle distance
Time Frame: Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Hand-axle distance during the recovery phase of propulsion assessed with video motion capture (VMC).
The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of the reflective markers, specifically on the axle and the third metacarpal joint.
The 3D infrared coordinates will be recorded while participants propel their wheelchair over the ground and on a dynamic roller system.
Hand-axle distance will be calculated by the magnitude of the vector formed by the third metacarpal joint and the axle.
The hand-axle will be compared across the three testing sessions.
This variable corresponds to the recommendations outlined in the clinical practice guidelines.
We hypothesize that the increase of hand-axle distance will be greater in the training group than the control group.
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Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Wheelchair Propulsion Test (WPT) - changes in effectiveness
Time Frame: Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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The WPT assesses wheelchair mobility and performance of manual wheelchair users (MWU).
The WPT requires MWU to propel using a self-selected natural velocity across 10 meters of a smooth flat surface from a static start.
The number of pushes and the time will be recorded.
The effectiveness of the propulsion is the displacement per push and will be calculated by the 10 meters divided by the number of pushes.
We hypothesize that the increase in the effectiveness of propulsion will be greater in the training group than the control group.
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Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Wheelchair Propulsion Test (WPT) - changes in cadence
Time Frame: Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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The WPT assesses wheelchair mobility and performance of manual wheelchair users (MWU).
The WPT requires MWU to propel using a self-selected natural velocity across 10 meters of a smooth flat surface from a static start.
The number of pushes and the time will be recorded.
The cadence of the propulsion is the number of push per second and will be calculated by the number of push divided by the time spent finishing the 10-meters line.
We hypothesize that the decrease of cadence will be greater in the training group than the control group.
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Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Wheelchair Propulsion Test (WPT) - changes in propulsion pattern
Time Frame: Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
|
The WPT assesses wheelchair mobility and performance of manual wheelchair users (MWU).
The WPT requires MWU to propel using a self-selected natural velocity across 10 meters of a smooth flat surface from a static start.
The number of pushes and the time will be recorded.
Clinicians will also record whether"during the contact phases, did the subject generally begin the contact between the hands and the hand-rims behind the top dead center of the rear wheel?", and " during the recovery phases, did the subject generally use a path of the hands that was predominantly beneath the handrims?"
The clinician will provide his/her evaluation by answering the two questions.
It is expected that after the training, the subject will change his/her pattern from both "no" to both "yes".
These two questions are based on the clinical practice guidelines (CPG) and only when both answers are "yes", then the participant will be considered following CPG.
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Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Outdoor propulsion - ratio of efficient propulsion pattern
Time Frame: Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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During the outdoor propulsion session, participants will push their wheelchair in an outdoor, asphalt surface parking lot with no ceiling for approximately three to five minutes across approximately 200 meters.
The parking lot consists of 5°-10°slopes, a flat surface with small potholes, and two small bumps/thresholds.
Participants will be told to propel their wheelchair at their regular speed in the parking lot.
An experimenter will follow the participant with a body harnessed action camera to record participant's left side propulsion.
A video coder will be viewing the recording then judge whether each push with the two questions mentioned in WPT form.
The changes in propulsion patterns will be calculated by the amount of CPG-based propulsion divided by the total amount of propulsion.
We hypothesize that the ratio increases of the CPG-based propulsion will be greater in the training group than controls.
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Baseline, 3-week after baseline for the control group/immediate after training group intervention, 3-weeks after second assessment
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Collaborators and Investigators
Publications and helpful links
General Publications
- MacPhee AH, Kirby RL, Coolen AL, Smith C, MacLeod DA, Dupuis DJ. Wheelchair skills training program: A randomized clinical trial of wheelchair users undergoing initial rehabilitation. Arch Phys Med Rehabil. 2004 Jan;85(1):41-50. doi: 10.1016/s0003-9993(03)00364-2.
- Kirby RL, Dupuis DJ, Macphee AH, Coolen AL, Smith C, Best KL, Newton AM, Mountain AD, Macleod DA, Bonaparte JP. The wheelchair skills test (version 2.4): measurement properties. Arch Phys Med Rehabil. 2004 May;85(5):794-804. doi: 10.1016/j.apmr.2003.07.007.
- Klaesner J, Morgan KA, Gray DB. The development of an instrumented wheelchair propulsion testing and training device. Assist Technol. 2014 Spring;26(1):24-32. doi: 10.1080/10400435.2013.792020.
- Boninger ML, Souza AL, Cooper RA, Fitzgerald SG, Koontz AM, Fay BT. Propulsion patterns and pushrim biomechanics in manual wheelchair propulsion. Arch Phys Med Rehabil. 2002 May;83(5):718-23. doi: 10.1053/apmr.2002.32455.
- Morgan KA, Tucker SM, Klaesner JW, Engsberg JR. A motor learning approach to training wheelchair propulsion biomechanics for new manual wheelchair users: A pilot study. J Spinal Cord Med. 2017 May;40(3):304-315. doi: 10.1080/10790268.2015.1120408. Epub 2015 Dec 16.
- 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.
- Morgan 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.
- Paralyzed Veterans of America Consortium for Spinal Cord Medicine. Preservation of upper limb function following spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2005;28(5):434-70. doi: 10.1080/10790268.2005.11753844. No abstract available.
- Sawatzky B, DiGiovine C, Berner T, Roesler T, Katte L. The need for updated clinical practice guidelines for preservation of upper extremities in manual wheelchair users: a position paper. Am J Phys Med Rehabil. 2015 Apr;94(4):313-24. doi: 10.1097/PHM.0000000000000203.
- Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.
- Axelson, P., Chesney, D. Y., Minkel, J., & Perr, A. (1996). The manual wheelchair training guide. Santa Cruz, CA: Pax Press,1996.
- Rice IM, Pohlig RT, Gallagher JD, Boninger ML. Handrim wheelchair propulsion training effect on overground propulsion using biomechanical real-time visual feedback. Arch Phys Med Rehabil. 2013 Feb;94(2):256-63. doi: 10.1016/j.apmr.2012.09.014. Epub 2012 Sep 26.
- DeGroot KK, Hollingsworth HH, Morgan KA, Morris CL, Gray DB. The influence of verbal training and visual feedback on manual wheelchair propulsion. Disabil Rehabil Assist Technol. 2009 Mar;4(2):86-94. doi: 10.1080/17483100802613685.
- Rice LA, Smith I, Kelleher AR, Greenwald K, Boninger ML. Impact of a wheelchair education protocol based on practice guidelines for preservation of upper-limb function: a randomized trial. Arch Phys Med Rehabil. 2014 Jan;95(1):10-19.e11. doi: 10.1016/j.apmr.2013.06.028. Epub 2013 Jul 13.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Congenital Abnormalities
- Trauma, Nervous System
- Spinal Cord Diseases
- Nervous System Malformations
- Neural Tube Defects
- Multiple Sclerosis
- Spinal Cord Injuries
- Spinal Dysraphism
Other Study ID Numbers
- 201711056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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