NCT01184742

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 22, 2014

Status Verified

November 1, 2011

Enrollment Period

3.8 years

First QC Date

August 18, 2010

Last Update Submit

July 21, 2014

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

  • 6 Minute Push Test

    Visit 3 and 4

  • 30 Second Sprint Test

    Visit 3 and 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of persons with spinal cord injury.

You may qualify if:

  • at least 1 year post-injury
  • able to self-propel a manual wheelchair
  • spinal cord injury between C5 and T5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Mark S Nash, PhD

    University of Miami, The Miami Project to Cure Paralysis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 22, 2014

Record last verified: 2011-11

Locations

US(1)