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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01184742
Other study ID # TMP-MN-001
Secondary ID
Status Completed
Phase N/A
First received August 18, 2010
Last updated July 21, 2014
Start date March 2010
Est. completion date January 2014

Study information

Verified date November 2011
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the relationship between physical fitness and wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers; and 3) self-reported avoidance of environmental features.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- at least 1 year post-injury

- able to self-propel a manual wheelchair

- spinal cord injury between C5 and T5

Exclusion Criteria:

- spinal cord injury above C5 or below T5

- spinal cord injury severity of AIS D

- unstable angina or myocardial infarction within the past month

- resting heart rate >120

- systolic blood pressure >180 mm Hg, or diastolic blood pressure >100 mm HG

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Miami Project to Cure Paralysis Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Paralyzed Veterans of America

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Minute Push Test Visit 3 and 4 No
Primary 30 Second Sprint Test Visit 3 and 4 No
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