NCT01831414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

3.8 years

First QC Date

April 11, 2013

Last Update Submit

May 3, 2013

Conditions

Spinal Cord Injury

Keywords

Lung functionWater immersionBalneotherapy

Outcome Measures

Primary Outcomes (1)

  • Lung volumes

    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 Outcomes (1)

  • Respiratory comfort

    1 hour

Study Arms (2)

Water immersion at cervical level

EXPERIMENTAL

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

Other: Water immersion at cervical level

Water immersion at xyphoid level

EXPERIMENTAL

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

Other: Water immersion at xyphoid level

Interventions

Water immersion at cervical levelOTHER

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

Water immersion at cervical level
Water immersion at xyphoid levelOTHER

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

Water immersion at xyphoid level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patient
  • complete tetraplegia from spinal cord injury
  • initial spinal cord injury at leat 3 months before study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • HELENE PRIGENT, MDPHD

    HOPITAL RAYMOND POINCARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 15, 2013

Study Start

June 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

FR(1)