Physical Disability Clinical Trial
Official title:
Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
NCT number | NCT03469414 |
Other study ID # | CKNF-1703 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | March 31, 2018 |
Est. completion date | February 1, 2021 |
Verified date | February 2021 |
Source | Allina Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Courage Kenny Rehabilitation Institute | Golden Valley | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Allina Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Life Space Assessment Scale Score | 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 | Distance (meters) covered in six-minute push test | 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 | |
Secondary | Average time to complete 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 | Day 0 | |
Secondary | Time to complete Manual 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 | Day 0 |
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