NCT01197599

Brief Summary

The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with spinal cord injury and able-bodied controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Typical duration 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

December 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 9, 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

3.2 years

First QC Date

August 18, 2010

Last Update Submit

July 21, 2014

Conditions

Spinal Cord Injury

Keywords

Healthy Control

Outcome Measures

Primary Outcomes (1)

  • Nerve cross-sectional area

    Nerve cross-sectional area will be measured via ultrasound. Images will be collected at least once (pre-activity) and up to every 10 minutes over an hour (post-activity).

    1 day (Visit 1)

Study Arms (2)

Spinal Cord Injury

Able-Bodied Control

Eligibility Criteria

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

Community sample of persons with spinal cord injury or healthy volunteers.

You may qualify if:

  • Spinal Cord Injury Cohort:
  • any cause or severity of spinal cord injury
  • at least 1 year post-injury
  • Able-Bodied Control Cohort:
  • self-reported good health

You may not qualify if:

  • history of non-dominant traumatic upper extremity injury to both wrist and shoulder
  • history of cardiopulmonary or other disease for which intense activity carries any risk of harm
  • a progressive or degenerative disability

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 CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2010

First Posted

September 9, 2010

Study Start

December 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)