Adaptive Auditive Cueing as a Therapy for Freezing of Gait in Parkinson Patients (BioFOGP-IPD1)

February 17, 2020 updated by: Ceriter Nederland BV

Biofeedback to Reduce Freezing of Gait in Parkinson Patients - Ceriter/Insole Parkinson Disease (IPD)-1

The first goal of the study is to investigate whether an algorithm can reliably detect Freezing of Gait (FOG) in Parkinson patients based on participant gait data generated by a pressure insole. The second goal is to investigate whether Auditive Cueing (AC) based on such a detection reduces the frequency and length of FOG episodes in those participants.

The study will be conducted per Good Clinical Practice principles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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 Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
          • Christophe Smeets, PhD medical

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

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • must have more than 1 FOG episode/day
  • must be patient in Ziekenhuis Oost Limburg (ZOL)

Exclusion Criteria:

  • not able to speak Dutch
  • cannot give informed consent (mental health)

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single group
Device: Auditive cueing
Based on gait measurement, auditive cueing is generated automatically to check its impact on patients with Freezing Of Gait.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The F1-score of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Time Frame: 8 walks are performed in 1 hospital visit within 4 weeks of enrollment. Total assessment time estimate is 2x 30 minutes.

The participants perform 4 walks without AC on standardized tracks while being video-recorded. During the walks, gait data is recorded and then scored (for each time point) by the algorithm into normal walk or FOG. The video recording is scored manually according to the criteria as described in reference Gilat. M. and represents the true state of walking.

The F1-score is calculated from the algorithm scoring vs the manual scoring: a True Positive is true freezing which is classified by the algorithm as freezing. A True Negative is a true normal walk which is classified as a normal walk. Similarly, a False Positive is a true normal walk which is classified as FOG and a False Negative is a true FOG which is classified as a normal walk.

The same 4 walks are performed both in OFF and in ON. OFF measurement is only performed when the PI has given permission to do so. ON measurement is performed 1 hour after taking their standard medication.
8 walks are performed in 1 hospital visit within 4 weeks of enrollment. Total assessment time estimate is 2x 30 minutes.
The change in the number of FOG-episodes with and without AC
Time Frame: 1 week after the first hospital visit (for Outcome 1).

The participants again perform 4 walks in OFF and in ON but now with AC.

The average number of freezing episodes is calculated for each participant in OFF and in ON with and without AC. The change between the average without AC and the average with AC is calculated as well as its level of significance. These changes are computed for each walk, for each individual participant across all walks and across all participants.
1 week after the first hospital visit (for Outcome 1).
The change in the total duration of FOG-episodes with and without AC
Time Frame: within 1 to 3 weeks after the first hospital visit

The participants again perform 4 walks in OFF and in ON but now with AC.

The average duration of freezing episodes is calculated in the same way as their number per Outcome 2.
within 1 to 3 weeks after the first hospital visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Time Frame: Within 4 weeks of enrollment
Same data collection as for outcome 1. Sensitivity is calculated from the algorithm scoring vs the manual scoring.
Within 4 weeks of enrollment
The specificity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Time Frame: within 1 to 3 weeks after the first hospital visit
Same data collection as for outcome 1. Specificity is calculated from the algorithm scoring vs the manual scoring.
within 1 to 3 weeks after the first hospital visit

Collaborators and Investigators

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

Sponsor

Ceriter Nederland BV

Collaborators

Ziekenhuis Oost Limburg (ZOL) Hospital Genk, Belgium

Investigators

  • Principal Investigator: An Driesen, MD, Neurologist, ZOL Genk

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

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)

June 6, 2019

Primary Completion (Anticipated)

May 22, 2020

Study Completion (Anticipated)

May 22, 2020

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioFOGP-IPD-1-ZOL

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.

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