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

NCT06204081 | Completed

• 1 other identifier: ONZ - 2023 - 0501
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• The number of captured episodes with freezing of gait (FOG)

  n (number of captured FOG-episodes : the less, the better)

  2 times 3 minutes

• The number of captured steps

  n (number - more steps relate to a better mobility)

  2 times 3 minutes

• The difference between the pressure of steps with left versus right foot; as a measure of gait asymmetry.

  mean presure data of left foot versus mean pressure data of right foot

  2 times 3 minutes

• mean step length

  mean step length (cm)

  2 times 3 minutes

Secondary Outcomes (1)

• users satisfaction

  after testing (5 min)

Study Arms (1)

persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG

EXPERIMENTAL

This group tests first without the use of cues (CSO evaluates gait pattern, but does not adjust), and then with cues.

Device: CSO_without cueing; Device: CSO_cueing

Interventions

CSO_without cueing DEVICE

The sole is worn without using the cueing application

persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG

CSO_cueing DEVICE

The sole is worn with using the cueing application

persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• Zoetewei D, Herman T, Brozgol M, Ginis P, Thumm PC, Ceulemans E, Decaluwe E, Palmerini L, Ferrari A, Nieuwboer A, Hausdorff JM. Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease. Contemp Clin Trials Commun. 2021 Jun 29;24:100817. doi: 10.1016/j.conctc.2021.100817. eCollection 2021 Dec.

  PMID: 34816053 RESULT

Related Links

• protocol of the DeFOG trial

MeSH Terms

Conditions

Gait Disorders, Neurologic; Parkinson Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Dirk Cambier, PhD

  UGent, FGE

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: One experimental group of pwP (H\&Y stage 4, FOG) wear the sole a. 3 min. without using cues when FOG appears and b. 3 min. with using auditive cues when FOG appears. By randomisation of the conditions, the effect of cues on gait is studied.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 12, 2024
• Study Start: December 5, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)