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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01084512
Other study ID # 9461701293
Secondary ID
Status Completed
Phase N/A
First received March 8, 2010
Last updated March 9, 2010
Start date July 2005
Est. completion date July 2008

Study information

Verified date February 2010
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- (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.

Exclusion Criteria:

- (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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan School and graduate institute of physical therapy Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chest wall motion 6 months after spinal cord injury No
Secondary ultrasonography 6 months after spinal cord injury No
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