NCT06164652: CSO-validity

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

Completed NA Last updated 6 June 2024

What this trial tests

NA trial testing walking with Ceriter Stride One in Healthy in 59 participants. Completed in 14 May 2024.

Timeline

30 November 2023

Primary endpoint
14 May 2024

14 May 2024

Quick facts

Lead sponsor	University Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	59
Start date	30 November 2023
Primary completion	14 May 2024
Estimated completion	14 May 2024
Sites	1 location across Belgium

Drugs / interventions tested

• walking with Ceriter Stride One

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University Ghent

Who can join

Adults 18 to 80, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.