Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access

• ClinicalTrials.gov Identifier: NCT03469414
• Recruitment Status: Terminated
• First Posted: March 19, 2018
• Last Update Posted: February 15, 2021
• Sponsor: Allina Health System
• 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.

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

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

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