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

NCT ID: NCT01831414

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Water immersion at cervical level

Lung function of spinal cord injury patients will be studied with a water immersion at cervical level

Group Type EXPERIMENTAL

Water immersion at cervical level

Intervention Type OTHER

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

Water immersion at xyphoid level

Lung volumes of spinal cord injury patients will be studied with a Water immersion at xyphoid level

Group Type EXPERIMENTAL

Water immersion at xyphoid level

Intervention Type OTHER

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

Interventions

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Water immersion at cervical level

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

Intervention Type OTHER

Water immersion at xyphoid level

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Garches

OTHER

Sponsor Role collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HELENE PRIGENT, MDPHD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL RAYMOND POINCARE

Locations

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Hopital Raymond Poincare

Garches, Garches, France

Site Status

Countries

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France

Other Identifiers

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2009-A00246-51

Identifier Type: -

Identifier Source: org_study_id

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