Effect of Immersion Level on Respiratory Function of Spinal Cord Injury Patients During Balneotherapy

Spinal Cord Injury Clinical Trial

— BALNEORESPI  

Official title:

Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831414
• Other study ID #: 2009-A00246-51
• Status: Completed
• Phase: N/A
• First received: April 11, 2013
• Last updated: May 3, 2013
• Start date: June 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless environment and which is often used in patients with spinal cord injury. In normal subjects, water immersion generates a reduction in lung volumes. The effects of water immersion on the respiratory function of spinal cord injury patient (who are liable to present a respiratory failure secondary to paralysis) are not well known. They could be deleterious (by majoring respiratory failure)or beneficial (by mimicking the effect of a corset and improving respiratory function). Therefore, we are planning to study the effect of different water immersion levels on the respiratory function of spinal cord injury patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Patient

• complete tetraplegia from spinal cord injury

• initial spinal cord injury at leat 3 months before study

Exclusion Criteria:

• contra indication to a balneotherapy session (bed-sore, skin infection or irritation, urinary or fecal incontinency, tracheostomy, ongoing infection)

• unstable respiratory state (patient free of respiratory infection or encumbrance)

• refusal to participate to the protocol

• pregnancy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Water immersion at cervical level
balneotherapy session of spinal cord patients with a Water immersion at cervical level
• Water immersion at xyphoid level
balneotherapy session of spinal cord patients with a Water immersion at xyphoid level

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Fondation Garches

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung volumes	Measurement of lung volumes (Vital capacity, Forced Expiratory volume at 1 second and total lung capacity) measured by standard pulmonary function test	1 hour	No
Secondary	Respiratory comfort	Respiratory comfort is evaluated with a visual analogical scale (ranked from 0 to 10) and the Borg dyspnea score	1 hour	No