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

May 3, 2013 updated by: Centre d'Investigation Clinique et Technologique 805

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Water immersion at cervical level
Lung function of spinal cord injury patients will be studied with a water immersion at cervical level
Other: Water immersion at cervical level
balneotherapy session of spinal cord patients with a Water immersion at cervical level
Experimental: Water immersion at xyphoid level
Lung volumes of spinal cord injury patients will be studied with a Water immersion at xyphoid level
Other: Water immersion at xyphoid level
balneotherapy session of spinal cord patients with a Water immersion at xyphoid level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

Fondation Garches

Investigators

  • Principal Investigator: Helene PRIGENT, MDPHD, Hôpital Raymond Poincaré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A00246-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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