NCT01084512

Brief Summary

Objective: To investigate the movement strategy of breathing based on three-compartment model measured by optoelectronic plethysmography (OEP) and electromyography (EMG ) among individuals with and without spinal cord injury in supine posture during deep inspiration. Design: cross sectional repeated-measure with age matched control group. Setting: Motion Analysis Laboratory Participants: Seven tetraplegic and five paraplegic subjects and twelve age matched healthy controls were recruited. Intervention: Not applicable.

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 Jul 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
Last Updated

March 10, 2010

Status Verified

February 1, 2010

Enrollment Period

3 years

First QC Date

March 8, 2010

Last Update Submit

March 9, 2010

Conditions

Spinal Cord Injury

Keywords

kinematic analysis,three-compartment model,chest wall motion,spinal cord injury.

Outcome Measures

Primary Outcomes (1)

  • Chest wall motion

    6 months after spinal cord injury

Secondary Outcomes (1)

  • ultrasonography

    6 months after spinal cord injury

Study Arms (3)

Healthy group

control subjects

Paraplegic group

Paraplegic subjects

Tetraplegic group

tetraplegic subjects

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • (1) motor complete loss below level of injury with American Spinal Injury Association Classification (ASIA) class A or B19;
  • (2) post-injury duration at least 0.5 year;
  • (3) male subject due to high incidence rate in Taiwan20and the necessity of total exposure of the chest wall during the data collection.

You may not qualify if:

  • (1) with any traumatic history of the chest wall,
  • (2) with any respiratory disease and musculoskeletal problem that interfered with the experimental protocol;
  • (3) having infections during the data collection period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and graduate institute of physical therapy

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

July 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 10, 2010

Record last verified: 2010-02

Locations

TW(1)