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

March 14, 2024 updated by: University Ghent

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There is scientific evidence for making pwP stop at the onset of propulsion (when step length decreases and step frequency increases) in order to get the COG back within the base of support. Similarly, (auditory) cues are recommended to facilitate starting.

These principles are implemented with the CSO : the device makes the pmP stop at onset of propulsion and generates an auditory, rhythmic cue to facilitate starting and walking with larger steps (prevention).

This is an innovative application, not a standard-of-care intervention.

Protocol :

20 persons with Parkinson's disease (H&Y 4) (attending physical therapy at Movita).

The test proceeds in 3 stages : preparation / gait test / subjective evaluation :

Preparation

  • Info / IC
  • General data : age, sex, number of years since diagnosis, use of aids, medication, fall incidents last week (fall diary based on fall diary), (last intake) medication and current efficacy (VAS).
  • MDS-UPDRS-II (degree of dependence), nFOGQ, Montreal Cognitive Assessment (MOCA).

Clinical gait test :

The soles are placed in the patient's shoes. If the patient uses an assistive device in daily life, the test is performed with an assistive device.

Following procedure is done in a randomized order*:

- Walking without auditory cue: for 3 minutes, the patient is asked to walk back and forth at a comfortable pace on a 4-meter course through a doorway (start : 2 meters before the doorway, stop : 2 meters beyond the doorway) without any auditory support. If no freezing occurs during this period, pwP is asked to turn 360° in the doorway.

The first 1.5 minutes gait is performed without a double task, the next 1.5 minutes with a cognitive double task (100 - 3 = ... - 3 = ... -3 = ...).

- Walking with auditory cues: for 3 minutes the patient is asked to walk back and forth at a comfortable pace along a 4-meter course through a doorway (start : 2 meters in front of the doorway, stop : 2 meters beyond the doorway) with auditory cues given at the occurrence of a freeze. If no FOG occured, the pwP is asked to turn 360° in the doorway.

The first 1.5 minutes gait is performed without a dual task, the next 1.5 minutes with a cognitive dual task (100 - 3 = ... - 3 = ... -3 = ...).

After each condition (with - without auditory cueing) a short break (2 minutes) is taken, during which a Borg scale for fatigue is taken. After the second condition, satisfaction with the effect of the aid is questioned (see below).

The entire gait test is filmed (by a 2nd person). In this way data, including the number of freezing episodes, can be checked.

*Randomization of conditions: per 2 patients. The first patient draws a card indicating whether or not the patient starts with auditory cues while walking. The 2nd patient then starts with the other condition, and so on. Thus we obtain 10 patients starting with the auditory cueing condition and 10 without.

Parameters considered : duration/step, gait asymmetry (pressure of left foot vs. right foot), number of freezing periods, distance walked, number of steps, mean step length.

Satisfaction questions

  • On a scale of 1 to 10, how would you rate the level of comfort of the Ceriter Stride One?
  • On a scale of 1 to 10, how safe do you feel when using the Ceriter Stride One?
  • To what extent do you feel more secure, on a scale of 1 to 10, while walking by using the Ceriter Stride One?
  • Open question : do you have any comments, concerns or questions of your own?

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Ghent University
        • Contact:
        • Principal Investigator:
          • Dirk Cambier, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG
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
The sole is worn without using the cueing application
Device: CSO_cueing
The sole is worn with using the cueing application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of captured episodes with freezing of gait (FOG)
Time Frame: 2 times 3 minutes
n (number of captured FOG-episodes : the less, the better)
2 times 3 minutes
The number of captured steps
Time Frame: 2 times 3 minutes
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.
Time Frame: 2 times 3 minutes
mean presure data of left foot versus mean pressure data of right foot
2 times 3 minutes
mean step length
Time Frame: 2 times 3 minutes
mean step length (cm)
2 times 3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
users satisfaction
Time Frame: after testing (5 min)
comfort and safety of the tool are questioned on a scale of 1 to 10.
after testing (5 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Dirk Cambier, PhD, UGent, FGE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ - 2023 - 0501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on CSO_without cueing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe