- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517229
The Effect of Altered Gravity Condition on Postural Control (POSTURGRAV)
August 5, 2015 updated by: University Hospital, Caen
The scientific goal of this experiment is to evaluate changes in balance control in response to microgravity during reactive balance tasks.
For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions.
To induce postural responses among the test subjects, an electromagnetic maneuverable postural platform will be used in order to randomly elicit perturbations.
Postural reactions will be quantified by means of mechanical and electromyographic data.
In Addition, peripheral nerve stimulation will be used to assess the spinal excitability by means of H-reflex recordings.
H-reflex measurements were chosen as they allow reliable information about inhibitory and facilitatory mechanisms taking place at the spinal level.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
18
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
-
-
Basse-Normandie
-
Caen CEDEX, Basse-Normandie, France, 14032
- Recruiting
- Umr Ucbn/Inserm U1075 Comete
-
-
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
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers (men or women)
- Aged from 21 to 65
- Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who have given their written stated consent
- Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.
Exclusion Criteria:
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Person with medical history of neurological disorders
- Person with medical history of musculoskeletal disorders of the lower limbs, especially of the ankle and knee joint.
- Pregnant women
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
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: in balance control in response to microgravity
to evaluate changes in balance control in response to microgravity during reactive balance tasks compared to normal gravity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
balance skill, expressed by the postural sway in mm
Time Frame: baseline
|
baseline
|
neuromuscular activity, expressed by the Electromyograpy (EMG)-amplitudes
Time Frame: baseline
|
baseline
|
spinal excitability, expressed by H-Reflexes
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2012
Primary Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
July 23, 2015
First Submitted That Met QC Criteria
August 5, 2015
First Posted (Estimate)
August 6, 2015
Study Record Updates
Last Update Posted (Estimate)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-084
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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