- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01831414
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
-
-
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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
|
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
|
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.
Collaborators
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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