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Short-Term Effect Of Ceriter Stride One (CSO) on FOG and Falling in pwP

NCT06204081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-06-05

No results posted yet for this study

Summary

The Ceriter Stride One (CSO) is a "smart sole" with pressure sensors. The sole allows data on the displacement of the body's centre of gravity (COG), as well as spatiotemporal parameters, to be obtained via pressure recordings. Logarithms, released on the data captured by the sole, make it possible to recognise propulsion (forward movement of the CG), accompanied by a reduction in step length (festination) or feet remaining standing (freezing of gait). When the system registers incipient propulsion, an audio signal ("stop") is generated via an audio device and app on the mobile phone. The CSO aims to make the pwP stop before balance disturbance can occur, preventing further propulsion and falls.

The aim of the study is to explore the short-term effects of the CSO in terms of reducing (preventing) freezing of gait and fall risk in a pilot group of pwP whose functionality is limited (Hoehn and Yahr 4). Short-term impact on gait (episodes of freezing of gait, mean step length, mean gait speed) will be evaluated and user satisfaction surveyed.

Conditions

  • Gait, Festinating
  • Parkinson Disease
  • Device Adherence

Interventions

DEVICE

CSO_without cueing

The sole is worn without using the cueing application

DEVICE

CSO_cueing

The sole is worn with using the cueing application

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Dirk Cambier, PhD · UGent, FGE

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2024-05-14
Completion
2024-05-14

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204081 on ClinicalTrials.gov