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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date February 2021
Source Allina Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


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.
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.
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.
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.
Craig Handicap Assessment and Reporting Technique
A measure of social participation in individuals with SCI.
PART-O
The PART-O is a community participation measure.
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.

Locations

Country Name City State
United States Courage Kenny Rehabilitation Institute Golden Valley Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

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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