Spinal Cord InjuryPhase 3GarchoiseNCT01569360
Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury
A Phase 3 study testing Corset in people with Spinal Cord Injury and Tetraplegia, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia, Paraplegia
- What is being tested?
- Corset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 …)
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Tetraplegia, Paraplegia
- Being tested
- Corset
- Keywords
- Spinal cord injury, Tetraplegia, Paraplegia, Respiratory function, Corset
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Paraplegia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorsetDevice
the patients are assigned the use of a custome made corset during daytime
| Study group | Role | What they receive |
|---|---|---|
| Corset | Active comparator | the patients are assigned the use of a custome made corset during daytime Receives: Device: Corset |
| No corset | No intervention | the patients do not use a corset during daytime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (6)
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.
Measured: 30 minutes
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.
Measured: 15 minutes
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.
Measured: 5 minutes
Ashworth scale
Evaluation of spasticity with the Ashworth scale at day 0, 3 months, 6 months, 1 year and 2 years.
Measured: 5 minutes
Penn scale
Evaluation of spasticity with the Penn scale at day 0, 3 months, 6 months, 1 year and 2 years.
Measured: 5 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Prigent, MD, PHD, Principal investigator, Raymond Poincaré Hospital, Garches 92380 France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569360
- Sponsor's protocol ID
- P091121
- Acronym
- Garchoise
- Status last verified
- Feb 2012
- First submitted
- 26 Mar 2012
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01569360
- Acronym / sponsor ID
- Garchoise / P091121
- Conditions
- Spinal Cord Injury, Tetraplegia, Paraplegia
- Keywords
- Spinal cord injury, Tetraplegia, Paraplegia, Respiratory function, Corset
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Apr 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corset | Active comparator | Device: Corsetthe patients are assigned the use of a custome made corset during daytime |
| No corset | No intervention | –the patients do not use a corset during daytime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corsetthe patients are assigned the use of a custome made corset during daytime | Device | Corset |
Primary outcome
Vital capacity in the upright and supine position
Time frame: 1 hour
Measurement of the vital capacity in the upright and supine position at day 0, 3 months, 6 months, 1 year and 2 years.
6 secondary outcomes
Maximal respiratory pressures
Time frame: 30 minutes
Blood gases
Time frame: 15 minutes
Borg dyspnéa scale
Time frame: 5 minutes
Ashworth scale
Time frame: 5 minutes
Penn scale
Time frame: 5 minutes
Blood pressure
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Helene Prigent, MD, PHD principal investigator
Raymond Poincaré Hospital, Garches 92380 France
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corset in people with Spinal Cord Injury and Tetraplegia, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Vital capacity in the upright and supine position (time frame: 1 hour). 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 19 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.