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Completed

NCT Number: NCT01831414

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Raymond Poincare

Garches, 92380, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water immersion at cervical level

Other

balneotherapy session of spinal cord patients with a Water immersion at cervical level

Water immersion at xyphoid level

Other

balneotherapy session of spinal cord patients with a Water immersion at xyphoid level

Primary outcomes

  1. Lung volumes

    Time frame: 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 outcomes

  1. Respiratory comfort

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Fondation Garches

Registry information

Official study title

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

Acronym: BALNEORESPI

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2013
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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