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

NCT01569360 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-12-19

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury
  • Tetraplegia
  • Paraplegia

Interventions

DEVICE

Corset

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Helene Prigent, MD, PHD · Raymond Poincaré Hospital, Garches 92380 France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01569360 on ClinicalTrials.gov