Spinal Cord InjurySCINCT01084512
Chest Wall Kinematics and Respiratory Muscle Action During Supine Breathing in Individuals With and Without Spinal Cord Injury
An observational study of Spinal Cord Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2005to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and graduate institute of physical therapy
Taipei, Taiwan, 100
About this study
Official title: Phase 0 Study of Chest Wall Kinematics and Respiratory Muscle Action During Supine Breathing in Individuals With and Without Spinal Cord Injury.
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.
Read the detailed description
Main Outcome Measures: The volume changes of chest wall and respiratory electromyographic ( EMG ) muscle activity were measured simultaneously by OEP and surface EMG. The variables included volume changes (ΔV ), ratio of volume changes (ΔVr ), peak velocity of volume changes ( PV ), the percentage of peak velocity occurs ( PPV ) in three compartments (upper thorax, UT; lower thorax, LT; and abdominal compartment, AB), and Root Mean Square EMG ( RMS EMG ) of sternocleidomastoid and diaphragm (combined with intercostalmuscles).
Results: Ttetraplegic individuals had smallerΔVUT andΔVLT than those of control subjects(P< .006 and .006, respectively). Furthermore, the ΔVr of AB was greater than those of UT and LT( P< .006, .006, respectively), PVAB was smaller than PVLT ( P< .006), PPVUT was greater than PPVLT and PPVAB ( P< .008, .008, respectively ). The paraplegic subjects had smallerΔVLT than that of control subjects ( P< .006 ). ΔVr of UT was greater than that of LT, and both PVUT and PVAB were greater than PVLT ( P< .006 and .006, respectively). However, the paraplegic subjects preferred to all three compartments to achieve the maximal inspiration, like control group. In control group, onlyΔVAB was comparable with other compartments. ΔVr of UT was greater than LT, and PVUT was greater than PVLT and PVAB ( P<.006 and .006, respectively). For the RMS EMG, it demonstrated that average RMS EMG of two muscles in both tetraplegic and paraplegic group were greater than that in control group (P< .017 and .017, respectively).
Conclusion: The results applied the three-compartment model of chest wall to investigate the breathing pattern by OEP in individuals with and without SCI during inspiration of vital capacity breathing in supine posture. There were some interesting findings that (1) the tetraplegic subjects used AB contributed most volume changes, they can expand the AB more easily, and the UT took the responsibility to performed the final adjust during the inspiration; (2) the paraplegic subjects used UT contributed the most volume changes, they expanded the both UT and AB more easily, and all three compartment moved together during the inspiration; (3) the control subjects used UT to increase the most volume changes, they can expand UT more than the others, and all three compartments moved together during the inspiration phase, (4) the results of RMS EMG showed that the central neural drive in both tetraplegic and paraplegic subjects were greater than control group.
- Conditions
- Spinal Cord Injury
- Keywords
- kinematic analysis,, three-compartment model,, chest wall motion,, spinal cord injury.
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | control subjects | |
| Paraplegic group | Paraplegic subjects | |
| Tetraplegic group | tetraplegic subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest wall motion
Measured: 6 months after spinal cord injury
Secondary outcomes (1)
ultrasonography
Measured: 6 months after spinal cord injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJul 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084512
- Sponsor's protocol ID
- 9461701293
- Acronym
- SCI
- Status last verified
- Feb 2010
- First submitted
- 8 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Study of Chest Wall Kinematics and Respiratory Muscle Action During Supine Breathing in Individuals With and Without Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT01084512
- Acronym / sponsor ID
- SCI / 9461701293
- Conditions
- Spinal Cord Injury
- Keywords
- kinematic analysis,, three-compartment model,, chest wall motion,, spinal cord injury.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main Outcome Measures: The volume changes of chest wall and respiratory electromyographic ( EMG ) muscle activity were measured simultaneously by OEP and surface EMG. The variables included volume changes (ΔV ), ratio of volume changes (ΔVr ), peak velocity of volume changes ( PV ), the percentage of peak velocity occurs ( PPV ) in three compartments (upper thorax, UT; lower thorax, LT; and abdominal compartment, AB), and Root Mean Square EMG ( RMS EMG ) of sternocleidomastoid and diaphragm (combined with intercostalmuscles).
Results: Ttetraplegic individuals had smallerΔVUT andΔVLT than those of control subjects(P< .006 and .006, respectively). Furthermore, the ΔVr of AB was greater than those of UT and LT( P< .006, .006, respectively), PVAB was smaller than PVLT ( P< .006), PPVUT was greater than PPVLT and PPVAB ( P< .008, .008, respectively ). The paraplegic subjects had smallerΔVLT than that of control subjects ( P< .006 ). ΔVr of UT was greater than that of LT, and both PVUT and PVAB were greater than PVLT ( P< .006 and .006, respectively). However, the paraplegic subjects preferred to all three compartments to achieve the maximal inspiration, like control group. In control group, onlyΔVAB was comparable with other compartments. ΔVr of UT was greater than LT, and PVUT was greater than PVLT and PVAB ( P<.006 and .006, respectively). For the RMS EMG, it demonstrated that average RMS EMG of two muscles in both tetraplegic and paraplegic group were greater than that in control group (P< .017 and .017, respectively).
Conclusion: The results applied the three-compartment model of chest wall to investigate the breathing pattern by OEP in individuals with and without SCI during inspiration of vital capacity breathing in supine posture. There were some interesting findings that (1) the tetraplegic subjects used AB contributed most volume changes, they can expand the AB more easily, and the UT took the responsibility to performed the final adjust during the inspiration; (2) the paraplegic subjects used UT contributed the most volume changes, they expanded the both UT and AB more easily, and all three compartment moved together during the inspiration; (3) the control subjects used UT to increase the most volume changes, they can expand UT more than the others, and all three compartments moved together during the inspiration phase, (4) the results of RMS EMG showed that the central neural drive in both tetraplegic and paraplegic subjects were greater than control group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | –control subjects |
| Paraplegic group | – | –Paraplegic subjects |
| Tetraplegic group | – | –tetraplegic subjects |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (3 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chest wall motion
Time frame: 6 months after spinal cord injury
1 secondary outcome
ultrasonography
Time frame: 6 months after spinal cord injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest wall motion (time frame: 6 months after spinal cord injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2010.