Adaptive Auditive Cueing As a Therapy for Freezing of Gait in Parkinson Patients

NCT ID: NCT04274478

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2021-04-11

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single group

Group Type OTHER

Auditive cueing

Intervention Type DEVICE

Based on gait measurement, auditive cueing is generated automatically to check its impact on patients with Freezing Of Gait.

Interventions

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Auditive cueing

Based on gait measurement, auditive cueing is generated automatically to check its impact on patients with Freezing Of Gait.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziekenhuis Oost Limburg (ZOL) Hospital Genk, Belgium

UNKNOWN

Sponsor Role collaborator

Ceriter Nederland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An Driesen, MD, Neurologist

Role: PRINCIPAL_INVESTIGATOR

ZOL Genk

Locations

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

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Belgium

References

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Naghavi N, Miller A, Wade E. Towards Real-Time Prediction of Freezing of Gait in Patients With Parkinson's Disease: Addressing the Class Imbalance Problem. Sensors (Basel). 2019 Sep 10;19(18):3898. doi: 10.3390/s19183898.

Reference Type BACKGROUND
PMID: 31509999 (View on PubMed)

Nonnekes J, Janssen AM, Mensink SH, Oude Nijhuis LB, Bloem BR, Snijders AH. Short rapid steps to provoke freezing of gait in Parkinson's disease. J Neurol. 2014 Sep;261(9):1763-7. doi: 10.1007/s00415-014-7422-8. Epub 2014 Jun 24.

Reference Type BACKGROUND
PMID: 24957299 (View on PubMed)

Barthel C, Nonnekes J, van Helvert M, Haan R, Janssen A, Delval A, Weerdesteyn V, Debu B, van Wezel R, Bloem BR, Ferraye MU. The laser shoes: A new ambulatory device to alleviate freezing of gait in Parkinson disease. Neurology. 2018 Jan 9;90(2):e164-e171. doi: 10.1212/WNL.0000000000004795. Epub 2017 Dec 20.

Reference Type BACKGROUND
PMID: 29263221 (View on PubMed)

Zach H, Janssen AM, Snijders AH, Delval A, Ferraye MU, Auff E, Weerdesteyn V, Bloem BR, Nonnekes J. Identifying freezing of gait in Parkinson's disease during freezing provoking tasks using waist-mounted accelerometry. Parkinsonism Relat Disord. 2015 Nov;21(11):1362-6. doi: 10.1016/j.parkreldis.2015.09.051. Epub 2015 Oct 1.

Reference Type BACKGROUND
PMID: 26454703 (View on PubMed)

Ginis P, Heremans E, Ferrari A, Bekkers EMJ, Canning CG, Nieuwboer A. External input for gait in people with Parkinson's disease with and without freezing of gait: One size does not fit all. J Neurol. 2017 Jul;264(7):1488-1496. doi: 10.1007/s00415-017-8552-6. Epub 2017 Jun 26.

Reference Type BACKGROUND
PMID: 28653213 (View on PubMed)

Gilat M. How to Annotate Freezing of Gait from Video: A Standardized Method Using Open-Source Software. J Parkinsons Dis. 2019;9(4):821-824. doi: 10.3233/JPD-191700.

Reference Type BACKGROUND
PMID: 31524181 (View on PubMed)

Other Identifiers

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BioFOGP-IPD-1-ZOL

Identifier Type: -

Identifier Source: org_study_id

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