- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03469414
Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
February 11, 2021 updated by: Allina Health System
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Golden Valley, Minnesota, United States, 55422
- Courage Kenny Rehabilitation Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
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.
|
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 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.
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.
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.
A measure of social participation in individuals with SCI.
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.
|
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 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.
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.
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.
A measure of social participation in individuals with SCI.
The PART-O is a community participation measure.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0
|
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
|
Day 0
|
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
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Flinn, PhD, OTR/L, Allina Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2018
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
March 12, 2018
First Submitted That Met QC Criteria
March 15, 2018
First Posted (Actual)
March 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2021
Last Update Submitted That Met QC Criteria
February 11, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CKNF-1703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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