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Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03469414
Recruitment Status : Terminated (COVID-19 Pandemic made participant recruitment nonfeasible.)
First Posted : March 19, 2018
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Allina Health System

Brief Summary:
This is a cross-section correlational study that will examine the relationships between wheelchair speed, maneuverability, and endurance with community integration. By identifying which of these has the biggest contribution to community participation, the information will be used to justify continues therapy, to alter the focus of therapy, and to justify purchase of power or power assist wheelchairs when needed. Currently, therapists make the recommendation for a power or power assist chair based on their clinical judgement and the patient's experience, but there has been limited justification from the literature for these decisions. Finally, because the CHART measure is the gold standard in rehabilitation research for community integration, but has psychometric problems, we will use this opportunity to validate a new more psychometrically solid measure, the PART-O, against the CHART.

Condition or disease Intervention/treatment
Physical Disability Other: Life Space Assessment Scale Other: 6-Minute Push Test Other: Forward Push Test Other: Wheelchair Slalom Test Other: Craig Handicap Assessment and Reporting Technique Other: PART-O Other: GPS Tracking

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
Actual Study Start Date : March 31, 2018
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Group/Cohort Intervention/treatment
Wheelchair Mobility and Speed
This group will participate in activity-based measures employed in routine occupational and physical therapy practice to assess participants' wheelchair speed, maneuverability, and endurance. These measures include: the Life Space Assessment Scale, 6-Minute Push Test, Forward Push Test, Wheelchair Slalom Test, Craig Handicap Assessment and Reporting Technique, and PART-O.
Other: Life Space Assessment Scale
This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there.

Other: 6-Minute Push Test
The 6 Minute Push Test is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes.

Other: Forward Push Test
This measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score.

Other: Wheelchair Slalom Test
In this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter.

Other: Craig Handicap Assessment and Reporting Technique
A measure of social participation in individuals with SCI.

Other: PART-O
The PART-O is a community participation measure.

GPS Tracking
A GPS tracker will be placed on the wheelchairs of 25 individuals who consent to participate in this arm of the project. Using a GPS tracker will provide a direct measure of the community locations these participants go. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement.
Other: Life Space Assessment Scale
This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there.

Other: 6-Minute Push Test
The 6 Minute Push Test is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes.

Other: Forward Push Test
This measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score.

Other: Wheelchair Slalom Test
In this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter.

Other: Craig Handicap Assessment and Reporting Technique
A measure of social participation in individuals with SCI.

Other: PART-O
The PART-O is a community participation measure.

Other: GPS Tracking
A GPS tracker will be attached to the wheelchairs of a subset of participants for one week. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement.




Primary Outcome Measures :
  1. Life Space Assessment Scale Score [ Time Frame: Day 0 ]
    This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there. The locations vary from spaces within their home, immediately around their home, or outside of their neighborhood, city, county, state or nation. Their independent movement patterns will be classified as within the home, limited community mobility and full community mobility.


Secondary Outcome Measures :
  1. Distance (meters) covered in six-minute push test [ Time Frame: Day 0 ]
    This is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes

  2. Average time to complete forward push test [ Time Frame: Day 0 ]
    This measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score

  3. Time to complete Manual Wheelchair slalom Test [ Time Frame: Day 0 ]
    In this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
260 participants with disabilities who use manual wheelchairs for their primary mobility. Participants will be recruited from all Courage Kenny Rehabilitation Institute sites. Participants will have a mixture of diagnosis, with a minimum of 30 individuals with diagnosis of stroke and 30 individuals with diagnosis with spinal cord injury.
Criteria

Inclusion criteria include:

  • 18 years or older
  • presence of a physical disability
  • use of a manual wheelchair for primary mobility
  • living in the community.

Exclusion criteria would include:

  • individuals who have significant expressive or receptive language deficits (i.e. aphasia, verbal apraxia, etc.)
  • limb orthopedic conditions that would contraindicate speed and endurance testing, such as recent fractures or joint instability
  • cardiopulmonary resting heart rate of less than 50 or over 100, resting vitals of systolic blood pressure of > 200 or < 90, diastolic blood pressure of >110, resting O2 levels of less than 90 (ACSM, 205; Fletcher, et al., 1993).
  • any other cardiac symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469414


Locations
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United States, Minnesota
Courage Kenny Rehabilitation Institute
Golden Valley, Minnesota, United States, 55422
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: Nancy Flinn, PhD, OTR/L Allina Health
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Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT03469414    
Other Study ID Numbers: CKNF-1703
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No