Evaluation of Foot Mechanical Information on Static Task and Locomotion

NCT05170750 | Completed

• 1 other identifier: PIMOUSS
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postural Balance

Keywords

foam; locomotion; postural control; orthopaedic insoles

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Plantar discrimination disk

  Clinical assessment at baseline

• Stability self evaluation

  Clinical assessment at baseline

Study Arms (1)

Mechanical foot stimulation evaluation

EXPERIMENTAL

We have a 2 factors' interaction (vision and foot) with several levels. * foot: 4 levels =3 foams and a Control (CT) condition) * vision: 2 levels (open/close) A test will consist of maintaining a standing position on a stabilometric platform for 30s in a given condition. 3 trials are performed for each condition (combination of different levels) Between each trial: the subject is asked to self evaluate his stability. We evaluate the plantar discrimination with a discrimination disk. 5 foot zones are tested. 3/5 subjects from PIMOUSS1 are asked to be in PIMOUSS2. We have the interaction of 2 factors. foot: 2 levels (insole/CT) vision : 2 levels (open/close) A trial is the combination of the different levels while walking. It is repeated 5 times per condition. The participant will perform this task under several experimental conditions presented in a randomized order: * Trajectory: (straight ahead/90° turns) * Visual: (close/open) * Mechanical stimuli (CT/insole)

Other: Foams; Other: Foam / Orthopedic insole

Interventions

Foams OTHER

Every subject will perform 24 randomized trials on force platform.

Also known as: plastazote, orthomic, Depron

Mechanical foot stimulation evaluation

Foam / Orthopedic insole OTHER

3/5 of the initial population will perform static and locomotion task, with randomized conditions.

Also known as: foam, Insole

Mechanical foot stimulation evaluation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between 18 to 59 years
• Healthy subject

You may not qualify if:

• balance disorders
• be pregnant
• be in rehabilitation of the lower limb
• have a lower limb injury within the 3 last months
• blind

Sponsors & Collaborators

• University of Rennes 2: lead

Study Sites (2)

M2S laboratory

Bruz, Brittany Region, 35170, France

Location

IFPEK Rennes

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Interventions

Plastipore; Foot Orthoses

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Armel Cretual, PhD HDR

  University Rennes 2 - Sport science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be exposed to different foams under their feet but neither them, nor the investigator are aware of the expected differences in the effect of the foams. In the second part, neither the participant, nor the investigator know the result of the first experiment.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: All participants participate to the first experiment. As the outcomes are continuous variables, to be sure to identify a variability between subjects based on their plantar information, we select 3 separated groups (on CoP results) of the initial population. Based on their results, 3/5 of the initial population can be recruited for the second part of the experiment.

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 28, 2021
• Study Start: November 5, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

FR (2)