NCT01204047

Brief Summary

The specific aims of this study are: 1) to assess the test-retest reliability of a modification of an existing wheelchair propulsion assessment and 2) validate the modification against traditional measures of physical strength, power, and endurance in a group of persons with spinal cord injury (SCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

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, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

3.9 years

First QC Date

September 16, 2010

Last Update Submit

July 21, 2014

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Ability Score

    The ability score is the sum of the number of items successfully completed in the wheelchair propulsion assessment. There are 8 items in the assessement, which will be completed in the following order: 1) Figure of 8 Shape, 2) Doorstep Crossing, 3) Platform Ascent, 4) 15 meter sprint, 5) Ramp Ascent (5% grade), 6) Ramp Ascent (8% grade), 7) 150 meter propulsion, and 8) Timed Level Transfer.

    within a 14 day period

Secondary Outcomes (3)

  • Muscular strength

    1 day

  • Anaerobic power

    1 day

  • Cardiovascular endurance

    1 day

Eligibility Criteria

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

Community sample

You may qualify if:

  • Spinal Cord Injury
  • American Spinal Injury Association Impairment Scale (AIS) A-D
  • Self-reported ability to self-propel themselves in a manual wheelchair
  • Age 18 or older

You may not qualify if:

  • surgery within 6 months
  • pressure ulcer within 3 months
  • upper limb pain that limits completion of exercise
  • recurrent acute infection or illness requiring hospitalization or IV antibiotics
  • pregnancy
  • previous myocardial infarction or cardiac surgery

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 Miller School of Medicine, The Miami Project to Cure Paralysis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 17, 2010

Study Start

March 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

US(1)