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NCT06204081Completed

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

Exploration of the Short-term Effects and User Satisfaction of the Ceriter Stride One (CSO) Regarding the Prevention and Treatment of Freezing or Gait in Persons With Parkinson's Disease (pwP).

Source: ClinicalTrials.gov · Last updated 5 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
11 (actual)
First submitted
1 Dec 2023
Start date
5 Dec 2023
Primary completion date
14 May 2024
Lead sponsor
University Ghent
NCT number
NCT06204081

What you commit to

  • Study type: Interventional
  • Participants enrolled: 11
  • From 5 Dec 2023 to the primary completion date, 14 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • unable to walk 4m without assistance
  • MoCA \< 25
  • no FOG

Who the study is looking for

  • Parkinson's disease (or other Parkinsonism)
  • gait impairment with freezing of gait (FOG)
  • 18-80 years old
  • I.C. (informed consent)
  • Montreal Cognitive Assessment (MoCA) \>25

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ghent University
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.