Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury (Garchoise)
Primary Purpose
Spinal Cord Injury, Tetraplegia, Paraplegia
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Corset
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Tetraplegia, Paraplegia, Respiratory function, Corset
Eligibility Criteria
Inclusion Criteria:
- Adult patients ≥ 18ans
- Spinal cord injury with an ASIA score of A or B
- Spinal cord injury with an injury level from C5 to T8 (included)
- Initial injury < 4 months
- Previous medical examination
- Signed consent form
Exclusion Criteria:
- Unstable respiratory state (far from secondary infection or congestion episode)
- Refusal to participate to the study
- Pregnant or nursing women
- Previous corset use
- No affiliation to social security system
- Impossibility to sustain the sitting position for several weeks or months (due to skin sore or planned surgery …)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Corset
No corset
Arm Description
the patients are assigned the use of a custome made corset during daytime
the patients do not use a corset during daytime
Outcomes
Primary Outcome Measures
Vital capacity in the upright and supine position
Measurement of the vital capacity in the upright and supine position at day 0, 3 months, 6 months, 1 year and 2 years.
Secondary Outcome Measures
Maximal respiratory pressures
Measurement of non invasive maximal respiratory inspiratory (Pimax) and expiratory (Pemax) pressures in the upright position at day 0, 3 months, 6 months, 1 year and 2 years.
Blood gases
Measurement of blood gases (PO2, PCO2 and O2 saturation) at rest at day 0, 3 months, 6 months, 1 year and 2 years.
Borg dyspnéa scale
evaluation of dyspnea in the supine and in the upright position with the Borg dyspnea scale at day 0, 3 months, 6 months, 1 year and 2 years.
Ashworth scale
Evaluation of spasticity with the Ashworth scale at day 0, 3 months, 6 months, 1 year and 2 years.
Penn scale
Evaluation of spasticity with the Penn scale at day 0, 3 months, 6 months, 1 year and 2 years.
Blood pressure
Evaluation blood pressure in the upright and in the supine position at day 0, 3 months, 6 months, 1 year and 2 years.
Full Information
NCT ID
NCT01569360
First Posted
March 26, 2012
Last Updated
December 18, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01569360
Brief Title
Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury
Acronym
Garchoise
Official Title
Randomised Open Study of the Efficiency and Tolerance of the Use of a Corset on the Respiratory Function of Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Corsets are often used in the management of patients with a spinal cord injury. They may help to rigidify the patients' trunk which might help some patients to sit upright; their use may also reduce the sensation of dyspnea some patients have while sitting upright. Due to spinal cord injury, abdominal muscles are weakened which can contribute to alter the respiratory function of the patients. But the corset by rigidifying the abdominal wall can improve the efficiency of the respiratory muscles in some patients and reduce dyspnea in the sitting position for some patients. However, when patients with spinal cord injury are followed over time, one can observe that some patients discontinue corset use. The investigators observed that the patients who pursue the corset use still have a significant improvement of their respiratory function with the corset while the patients who have discontinued the use have improved their respiratory function in the upright position (without the corset). As of now, the investigators do not know whether the use of the corset is discontinued because of a spontaneous improvement of the respiratory function or whether discontinuing the use of the corset may help to develop abdominal spasticity and therefore to improve respiratory function. The investigators seek to investigate this issue in order to optimize the management of patients who present spinal cord injury.
Detailed Description
Corsets are widely used in the management of spinal cord injury (SCI) patients. Their use provides a certain amount of rigidity to the trunk which may help some patients to maintain posture; they also may contribute when used in combination with contention to reduce orthostatic hypotension. Last, they may reduce dyspnea and improve respiratory tolerance while sitting. Indeed, patients with recent SCI worsen their respiratory function in the sitting position secondary to the hypotonia of abdominal muscles which places the diaphragm in a lower and less efficient position. The use of a corset rigidifies the abdominal wall and therefore improves the diaphragm contraction's efficiency leading to an improvement of vital capacity (VC) and a reduction of dyspnea in the sitting position. But although some patients continue to use a corset overtime, others discontinue its use. We recently observed that corset users presented an improvement of VC with corset use proportional to the improvement of VC observed in the supine position while patients who had discontinued its use did not exhibit a reduction of VC between the supine and the upright position suggesting that they presented a more rigid abdominal wall.
It is not known whether corset use discontinuation results from the spontaneous improvement respiratory function in the upright position or leads to the appearance of abdominal spasticity and to the improvement of respiratory function.
Therefore, we aim to study the effect of the long term corset use on SCI patients' respiratory function.
We will conduct a monocentric prospective open study of 56 SCI patients (SCI level ranging from C5 to T8 ASIA A or B) with a recent lesion (<4 months). The evolution of respiratory function and dyspnea with and without corset use will be studied over a 2 years period. An evaluation of spasticity overtime will also be conducted. After randomization (corset use or not) evaluation will be conducted after 3 months, 6 months, 1 year and 2 years and will include: pulmonary function test with and without corset in the upright position and in the supine position, blood gases, dyspnea scores in the different positions and spasticity assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Tetraplegia, Paraplegia
Keywords
Spinal cord injury, Tetraplegia, Paraplegia, Respiratory function, Corset
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corset
Arm Type
Active Comparator
Arm Description
the patients are assigned the use of a custome made corset during daytime
Arm Title
No corset
Arm Type
No Intervention
Arm Description
the patients do not use a corset during daytime
Intervention Type
Device
Intervention Name(s)
Corset
Intervention Description
the patients are assigned the use of a custome made corset during daytime
Primary Outcome Measure Information:
Title
Vital capacity in the upright and supine position
Description
Measurement of the vital capacity in the upright and supine position at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Maximal respiratory pressures
Description
Measurement of non invasive maximal respiratory inspiratory (Pimax) and expiratory (Pemax) pressures in the upright position at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
30 minutes
Title
Blood gases
Description
Measurement of blood gases (PO2, PCO2 and O2 saturation) at rest at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
15 minutes
Title
Borg dyspnéa scale
Description
evaluation of dyspnea in the supine and in the upright position with the Borg dyspnea scale at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
5 minutes
Title
Ashworth scale
Description
Evaluation of spasticity with the Ashworth scale at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
5 minutes
Title
Penn scale
Description
Evaluation of spasticity with the Penn scale at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
5 minutes
Title
Blood pressure
Description
Evaluation blood pressure in the upright and in the supine position at day 0, 3 months, 6 months, 1 year and 2 years.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients ≥ 18ans
Spinal cord injury with an ASIA score of A or B
Spinal cord injury with an injury level from C5 to T8 (included)
Initial injury < 4 months
Previous medical examination
Signed consent form
Exclusion Criteria:
Unstable respiratory state (far from secondary infection or congestion episode)
Refusal to participate to the study
Pregnant or nursing women
Previous corset use
No affiliation to social security system
Impossibility to sustain the sitting position for several weeks or months (due to skin sore or planned surgery …)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Prigent, MD, PHD
Organizational Affiliation
Raymond Poincaré Hospital, Garches 92380 France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury
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