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

NCT01569360 | Withdrawn Phase 3 DMC

• 1 other identifier: P091121
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury; Tetraplegia; Paraplegia

Keywords

Spinal cord injury; Tetraplegia; Paraplegia; Respiratory function; Corset

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Maximal respiratory pressures

  30 minutes

• Blood gases

  15 minutes

• Borg dyspnéa scale

  5 minutes

• Ashworth scale

  5 minutes

• Penn scale

  5 minutes

Study Arms (2)

Corset

ACTIVE COMPARATOR

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

Device: Corset

No corset

NO INTERVENTION

the patients do not use a corset during daytime

Interventions

Corset DEVICE

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

Corset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 …)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paraplegia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Helene Prigent, MD, PHD

  Raymond Poincaré Hospital, Garches 92380 France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2012-02