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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05170750
Other study ID # PIMOUSS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2021
Est. completion date April 4, 2022

Study information

Verified date November 2022
Source University of Rennes 2
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sensory foot integration is evaluated by foam under feet both in research and clinical contexts. However, there is no norm defined regarding foam characteristics and this evaluation is mostly performed using a static task. Our goal is to better understand the impact of the modification of plantar information by foam both during static task and locomotion task. The purpose is to standardize evaluation methods and define reference values for a better follow-up and diagnosis of patients.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Foams
Every subject will perform 24 randomized trials on force platform.
Foam / Orthopedic insole
3/5 of the initial population will perform static and locomotion task, with randomized conditions.

Locations

Country Name City State
France M2S laboratory Bruz Bretagne
France IFPEK Rennes Rennes Bretagne

Sponsors (1)

Lead Sponsor Collaborator
University of Rennes 2

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of Pressure measurement between conditions Characteristics of centre of Pressure (CoP) will be registered for every 30s trial. The CoP movement during this 30s will be describe with its aera, velocity...
A within analysis will be perform between the 3 repetitions for each condition. A between analysis will be performed between the foot conditions.
30 seconds
Primary Plantar Quotient on CoP The plantar quotient is the ratio of the oscillation of CoP on foam to the oscillation of CoP on hard ground.
It will be calculated for each foam. It will be calculating using aera data and velocity data.
30 seconds
Primary Center of Mass (CoM) measurement between condition CoM projection will be analysed regarding foot position during locomotion
We will compare control condition to insole condition
Clinical assessment at baseline
Secondary Plantar discrimination disk Plantar discrimination will be quantify with a discrimination disk. 5 aera will be tested (big toe, 1st 3rd and 5th metatarsal head and heel) The subject must answer 3 times the same answer. The response corresponds to the distance between 2 spikes applied to the surface of the foot. The distance between the spikes varies between 2 mm and 20 mm.
2mm is the minimum response and corresponds to a more precise discrimination. As the distance between the tips increases, the discrimination becomes less accurate.
Clinical assessment at baseline
Secondary Stability self evaluation After each trial on force platform, the subject is asked to evaluate his stability perception using a scale (10cm). We reported the number (in cm) were the subject stops the cursor.
The scale is from 0 to 10 (0 is best stability and 10 is maximum unstability) The evaluation is done between each 30s trials (24 times)
Clinical assessment at baseline
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