NCT02517229

Brief Summary

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.

Trial Health

55
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Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

3.1 years

First QC Date

July 23, 2015

Last Update Submit

August 5, 2015

Conditions

Keywords

volunteers

Outcome Measures

Primary Outcomes (3)

  • balance skill, expressed by the postural sway in mm

    baseline

  • neuromuscular activity, expressed by the Electromyograpy (EMG)-amplitudes

    baseline

  • spinal excitability, expressed by H-Reflexes

    baseline

Study Arms (1)

in balance control in response to microgravity

OTHER

to evaluate changes in balance control in response to microgravity during reactive balance tasks compared to normal gravity.

Other: Parabolic flightOther: balance control measurementsDevice: electromagnetic maneuverable postural platform

Interventions

in balance control in response to microgravity
in balance control in response to microgravity
in balance control in response to microgravity

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

August 6, 2015

Study Start

September 1, 2012

Primary Completion

October 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations