Spinal Cord Injury Clinical Trial
— GarchoiseOfficial title:
Randomised Open Study of the Efficiency and Tolerance of the Use of a Corset on the Respiratory Function of Spinal Cord Injury Patients
Verified date | February 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 …) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 hour | No |
Secondary | 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. | 30 minutes | No |
Secondary | 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. | 15 minutes | No |
Secondary | 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. | 5 minutes | No |
Secondary | Ashworth scale | Evaluation of spasticity with the Ashworth scale at day 0, 3 months, 6 months, 1 year and 2 years. | 5 minutes | No |
Secondary | Penn scale | Evaluation of spasticity with the Penn scale at day 0, 3 months, 6 months, 1 year and 2 years. | 5 minutes | No |
Secondary | 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. | 5 minutes | No |
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