Motor Learning Approach for Manual Wheelchair Users

NCT ID: NCT03781609

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2021-07-30

Brief Summary

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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

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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).

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Roller system group (RG)

A group performing motor learning manual wheelchair propulsion repetitions on a roller system.

Group Type ACTIVE_COMPARATOR

Roller system group (RG)

Intervention Type BEHAVIORAL

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)

A group performing motor learning manual wheelchair propulsion repetitions overground.

Group Type ACTIVE_COMPARATOR

Overground group (OG)

Intervention Type BEHAVIORAL

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)

A group receiving conventional manual wheelchair skills training.

Group Type PLACEBO_COMPARATOR

Placebo - Wheelchair skills group (WSG)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerri A Morgan, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201804133

Identifier Type: -

Identifier Source: org_study_id

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