- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320097
A Study of the Impact of Head Position on Foot Pressure in Stance
A Study of the Impact of Head Position on Foot Pressure in Stance.
When examining a subject in quiet stance from the side, the leg segment is usually seen to be oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the shoulders are behind the great trochanter and the head is held forwards. The forward head position moves the center of gravity forwards and thus may increase pressure under the forefoot. Conversely, moving the head backwards should be accompanied by an increase in pressure under the heel and thus decreased pressure under the forefoot.
The study's objective is to study the influence of alignment of the head with the back (i.e. a rearward head position) and head rotation on the foot pressure distribution (measured using a foot pressure platform).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 30
- Social security coverage
- Ability to understand the study's objectives, procedures and risks and to provide informed, written consent
Exclusion Criteria:
- Past or concomitant infectious or cancerous diseases of the spine
- Vertebral osteosynthesis
- Acute neck or arm pain
- Limb trauma in the previous 12 months
- Acute leg pain
- Neuropathic disease or the sequelae of neuropathic disease of the legs
- Myasthenia gravis
- Central nervous system disorders
- Inner ear problems
- Subjects under legal guardianship
- Known pregnancy
- Simultaneous participation in another biomedical research study of a drug or medical device.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Foot pressure measurement
The subject stands on the platform, with the heels and buttocks touching a vertical plane and the head held freely. The subject then moves his/her head backwards so that it touches the vertical plane. Next, he/she turns the head to the right and then towards the left. Each of these positions is maintained for 2 minutes. The platform's sensors measure the anteroposterior foot pressure distribution during the various acquisitions. |
Description of the foot pressure measurement: The subject stands on the platform, with the heels and buttocks touching a vertical plane and the head held freely. The subject then moves his/her head backwards so that it touches the vertical plane. Next, he/she turns the head to the right and then towards the left. Each of these positions is maintained for 2 minutes. The platform's sensors measure the anteroposterior foot pressure distribution during the various acquisitions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The foot pressure in g/cm2 and the anteroposterior pressure distribution, measured using a foot pressure platform.
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mutter Catherine, MD, Les Hôpitaux Universitaires de Strasbourg
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5899
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