NCT03781609

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

2.7 years

First QC Date

November 21, 2018

Last Update Submit

October 4, 2021

Conditions

Keywords

manual wheelchairwheelchair propulsionoccupational therapymotor learning

Outcome Measures

Primary Outcomes (5)

  • Video Motion Capture-Hand Axle relationship Change

    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 \[hand-axle relationship\].

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Video Motion Capture-Push Angle Change

    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 \[push angle\].

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Wheelchair Propulsion Test (WPT)-Number of pushes Change

    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.

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Wheelchair Propulsion Test (WPT)-time to complete 10 meter push Change

    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.

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Wheelchair Propulsion Test (WPT)-type of propulsion pattern comparison between time points

    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.

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

Secondary Outcomes (4)

  • Outdoor Propulsion Test-Total push count

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Outdoor Propulsion Test-# of pushes meeting clinical guidelines

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Outdoor Propulsion Test-Type of propulsion pattern

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

  • Outdoor Propulsion Test-Time to complete route

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

Other Outcomes (1)

  • Wheelchair User's Shoulder Pain Index (WUSPI)

    Baseline, Up to 4 weeks post intervention and 3-month post intervention

Study Arms (3)

Roller system group (RG)

ACTIVE COMPARATOR

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

Behavioral: Roller system group (RG)

Overground group (OG)

ACTIVE COMPARATOR

A group performing motor learning manual wheelchair propulsion repetitions overground.

Behavioral: Overground group (OG)

Placebo - Wheelchair skills group (WSG)

PLACEBO COMPARATOR

A group receiving conventional manual wheelchair skills training.

Behavioral: Placebo - Wheelchair skills group (WSG)

Interventions

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.

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 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.

Overground group (OG)

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.

Placebo - Wheelchair skills group (WSG)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (125)

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Kerri A Morgan, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

December 20, 2018

Study Start

November 5, 2018

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations