Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury

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Brief Title

Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury

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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Vital capacity in the upright and supine position

Secondary Outcome

 Maximal respiratory pressures

Condition

Spinal Cord Injury

Intervention

Corset

Study Arms / Comparison Groups

 Corset
Description:  the patients are assigned the use of a custome made corset during daytime

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

March 2012

Completion Date

March 2013

Primary Completion Date

March 2013

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 …)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Helene Prigent, MD, PHD, , 



Administrative Informations


NCT ID

NCT01569360

Organization ID

P091121


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Helene Prigent, MD, PHD, Principal Investigator, Raymond Poincaré Hospital, Garches 92380 France


Verification Date

February 2012