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

NCT06164652 | Completed

• 1 other identifier: ONZ-2023-0104
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• step length

  n centimeter

  3 minutes

• step frequency / cadance

  n steps per minute

  3 minutes

• gait speed

  meter per second

  3 minutes

Study Arms (1)

Healthy adults (M/V/X, 18-80)

EXPERIMENTAL

Device: walking with Ceriter Stride One

Interventions

walking with Ceriter Stride One DEVICE

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

Healthy adults (M/V/X, 18-80)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy
• M/V/X

You may not qualify if:

• pregnancy
• injuries/lesions which make walking painful or difficult

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• Jacobs D, Farid L, Ferre S, Herraez K, Gracies JM, Hutin E. Evaluation of the Validity and Reliability of Connected Insoles to Measure Gait Parameters in Healthy Adults. Sensors (Basel). 2021 Sep 30;21(19):6543. doi: 10.3390/s21196543.

  PMID: 34640868 RESULT

Related Links

• The results showed no statistically significant differences between the data of the insoles compared to the data of the GAITRite. This means that the insoles are promising to assess clinically measurements of the gait pattern in pwPD.

Study Officials

• Dirk Cambier, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparing data (gait kinematics) gathered with GAITRite and Ceriter Stride One by walking at comfortable and increased speed

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: November 30, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)