Clinical trial NCT03781609: Motor Learning Approach for Manual Wheelchair Users
Official title: A Motor Learning Approach to Wheelchair Propulsion Training for Manual Wheelchair Users With SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: manual wheelchair
wheelchair propulsion
occupational therapy
motor learning
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2018-12-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility 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.

Primary outcomes:
measure: Video Motion Capture-Hand Axle relationship Change
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Video Motion Capture-Push Angle Change
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Wheelchair Propulsion Test (WPT)-Number of pushes Change
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Wheelchair Propulsion Test (WPT)-time to complete 10 meter push Change
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Wheelchair Propulsion Test (WPT)-type of propulsion pattern comparison between time points
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Secondary outcomes:
measure: Outdoor Propulsion Test-Total push count
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Outdoor Propulsion Test-# of pushes meeting clinical guidelines
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Outdoor Propulsion Test-Type of propulsion pattern
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
measure: Outdoor Propulsion Test-Time to complete route
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Other outcomes:
measure: Wheelchair User's Shoulder Pain Index (WUSPI)
timeFrame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kerri A Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
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