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

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Other: Water immersion at cervical level; Other: Water immersion at xyphoid level

• Registration Number: NCT01831414
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-15
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Water immersion at cervical level	Water immersion at cervical level	Lung function of spinal cord injury patients will be studied with a water immersion at cervical level
Water immersion at xyphoid level	Water immersion at xyphoid level	Lung volumes of spinal cord injury patients will be studied with a Water immersion at xyphoid level

Primary Outcome Measures

Name	Time	Method
Lung volumes	1 hour	Measurement of lung volumes (Vital capacity, Forced Expiratory volume at 1 second and total lung capacity) measured by standard pulmonary function test

Secondary Outcome Measures

Name	Time	Method
Respiratory comfort	1 hour	Respiratory comfort is evaluated with a visual analogical scale (ranked from 0 to 10) and the Borg dyspnea score

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France