search
Back to results

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Withdrawn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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 26, 2012
    Last Updated
    December 18, 2013
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    search

    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

    We'll reach out to this number within 24 hrs