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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

Tracking Information
First Submitted Date March 12, 2018
First Posted Date March 19, 2018
Last Update Posted Date February 15, 2021
Actual Study Start Date March 31, 2018
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2018)
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.
Original Primary Outcome Measures
 (submitted: March 15, 2018)
Life Space Assessment Scale Score [ Time Frame: During single and only study visit. ]
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.
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: March 15, 2018)
  • Distance (meters) covered in six-minute push test [ Time Frame: During single and only study visit. ]
    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
  • Average time to complete forward push test [ Time Frame: During single and only study visit. ]
    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
  • Time to complete Manual Wheelchair slalom Test [ Time Frame: During single and only study visit. ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
Official Title Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Physical Disability
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 11, 2021)
1
Original Estimated Enrollment
 (submitted: March 15, 2018)
260
Actual Study Completion Date February 1, 2021
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03469414
Other Study ID Numbers CKNF-1703
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Allina Health System
Original Responsible Party Nancy Flinn, Allina Health System, Senior Scientific Advisor
Current Study Sponsor Allina Health System
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Nancy Flinn, PhD, OTR/L Allina Health
PRS Account Allina Health System
Verification Date February 2021