Evaluation of the Validity of the Ceriter Stride One in Measuring Gait and Pressure Parameters in Healthy Adults

Summary

The Ceriter Stride One is a certified medical device that aims to provide a better, more independent and safe gait pattern for people with neurological disorders, such as Parkinson's disease. The Stride One detects the (abnormal) gait pattern via an insole with pressure sensors and generates customised audio feedback (app), e.g. to avoid or correct Freezing or Gait (Parkinson's).

To gain more insight into the accuracy of the pressure and gait recordings, we want to compare them with those of the GAITRite. The GAITRite is an electronic walking carpet with an active zone 7.32m long and 0.61m wide. The carpet has pressure sensors embedded in horizontal lines. When a person steps on the carpet, these sensors capture the pressure distribution which, with the help of an algorithm, allows the collection of parameters per time unit (including speed, step time, stride time, cadence, etc.) and space (step and stride length, step and stride width, etc.). The GAITrite is considered a gold standard for capturing temporal and spatial data related to gait pattern.

Our research question can be answered by having healthy subjects step over the GAITRite with the Ceriter Stride One on, and then checking the agreement between spatiotemporal factors.

Thus, after IC and recording of administrative data, healthy adults will be invited for this cross-sectional validity study of a pressure-sensitive insole (Ceriter Stride One) against the validated and reliable gold standard, the GaitRite.

At intake, the informed consent is gone over and signed. The inclusion and exclusion criteria are then questioned in a short interview. Inclusion criteria are pain-free and safe walking. Exclusion criteria are pregnancy and (congenital or acquired) orthopaedic, neurological and other defects that make walking without a walking aid or orthosis (or shoe adaptation) painful, difficult and/or unsafe,

Ceriter insoles are placed in the test subjects' shoes, if possible in place of their own insoles, in case of orthotics on top. Via a Bluetooth transmitter, the captured signals from the pressure sensors are transmitted to and mobile phone and then via the internet to Ceriter's data portal where they are further processed and, for the purpose of this study, made available to the researchers.Subjects then step on the walking carpet with sensors (GAITRite) with these insoles in their shoes.Both systems record the pressures and analyse the gait pattern from there.

Each test subject is expected to step across the walking carpet at a comfortable pace for three full lengths and 3 lengths involving acceleration. This, fitted with the insoles, so that sufficient steps are available to average out step parameters.

The aim of the study is thus to find out to what extent the spatiotemporal parameters captured with the Ceriter Stride One coincide with those of the GaitRite.

Conditions

• Healthy

Interventions

DEVICE

walking with Ceriter Stride One

Subjects walk on the GAITRite with the CSO insole in their shoes.

Sponsors & Collaborators

• University Ghent

  lead OTHER

Principal Investigators

• Dirk Cambier, PhD · University Ghent

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-30

Primary Completion

2024-05-14

Completion

2024-05-14

Countries

• Belgium

Study Locations