Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries Multiple Sclerosis Amputation Spina Bifida | Behavioral: In-person wheelchair propulsion training program Behavioral: 30-minute education session | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of a Wheelchair Propulsion Training Program for Manual Wheelchair Users: a Pilot Study |
Actual Study Start Date : | March 27, 2018 |
Actual Primary Completion Date : | October 22, 2019 |
Actual Study Completion Date : | October 22, 2019 |
Arm | Intervention/treatment |
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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.
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Behavioral: In-person wheelchair propulsion training program
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.
Behavioral: 30-minute education session 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.
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Behavioral: 30-minute education session
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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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63108 |
Principal Investigator: | Kerri Morgan, PhD | Washington University School of Medicine |
Tracking Information | |||||
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First Submitted Date ICMJE | July 1, 2019 | ||||
First Posted Date ICMJE | July 5, 2019 | ||||
Last Update Posted Date | April 8, 2020 | ||||
Actual Study Start Date ICMJE | March 27, 2018 | ||||
Actual Primary Completion Date | October 22, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Wheelchair Propulsion Training Program | ||||
Official Title ICMJE | Efficacy of a Wheelchair Propulsion Training Program for Manual Wheelchair Users: a Pilot Study | ||||
Brief Summary | The overall purpose of this project is to test the feasibility of a manual wheelchair propulsion program which aims to reduce the chance of development of upper limbs pain and injury. | ||||
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? |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | October 22, 2019 | ||||
Actual Primary Completion Date | October 22, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04009187 | ||||
Other Study ID Numbers ICMJE | 201711056 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Kerri Morgan, Washington University School of Medicine | ||||
Study Sponsor ICMJE | Washington University School of Medicine | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Washington University School of Medicine | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |