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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Auditive cueing
Sponsored by
Ceriter Nederland BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ziekenhuis Oost-LimburgRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single group

Arm Description

Outcomes

Primary Outcome Measures

The F1-score of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
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.
The change in the number of FOG-episodes with and without AC
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.
The change in the total duration of FOG-episodes with and without AC
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.

Secondary Outcome Measures

The sensitivity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Same data collection as for outcome 1. Sensitivity is calculated from the algorithm scoring vs the manual scoring.
The specificity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Same data collection as for outcome 1. Specificity is calculated from the algorithm scoring vs the manual scoring.

Full Information

First Posted
February 2, 2020
Last Updated
February 17, 2020
Sponsor
Ceriter Nederland BV
Collaborators
Ziekenhuis Oost Limburg (ZOL) Hospital Genk, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT04274478
Brief Title
Adaptive Auditive Cueing as a Therapy for Freezing of Gait in Parkinson Patients
Acronym
BioFOGP-IPD1
Official Title
Biofeedback to Reduce Freezing of Gait in Parkinson Patients - Ceriter/Insole Parkinson Disease (IPD)-1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
May 22, 2020 (Anticipated)
Study Completion Date
May 22, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceriter Nederland BV
Collaborators
Ziekenhuis Oost Limburg (ZOL) Hospital Genk, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Auditive cueing
Intervention Description
Based on gait measurement, auditive cueing is generated automatically to check its impact on patients with Freezing Of Gait.
Primary Outcome Measure Information:
Title
The F1-score of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Description
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.
Time Frame
8 walks are performed in 1 hospital visit within 4 weeks of enrollment. Total assessment time estimate is 2x 30 minutes.
Title
The change in the number of FOG-episodes with and without AC
Description
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.
Time Frame
1 week after the first hospital visit (for Outcome 1).
Title
The change in the total duration of FOG-episodes with and without AC
Description
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.
Time Frame
within 1 to 3 weeks after the first hospital visit
Secondary Outcome Measure Information:
Title
The sensitivity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Description
Same data collection as for outcome 1. Sensitivity is calculated from the algorithm scoring vs the manual scoring.
Time Frame
Within 4 weeks of enrollment
Title
The specificity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
Description
Same data collection as for outcome 1. Specificity is calculated from the algorithm scoring vs the manual scoring.
Time Frame
within 1 to 3 weeks after the first hospital visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Smeets, PhD, medical
Phone
+32 89 21 20 11
Email
Christophe.Smeets@zol.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Driesen, MD, Neurologist
Organizational Affiliation
ZOL Genk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Smeets, PhD medical

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31509999
Citation
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.
Results Reference
background
PubMed Identifier
24957299
Citation
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.
Results Reference
background
PubMed Identifier
29263221
Citation
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.
Results Reference
background
PubMed Identifier
26454703
Citation
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.
Results Reference
background
PubMed Identifier
28653213
Citation
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.
Results Reference
background
PubMed Identifier
31524181
Citation
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.
Results Reference
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Adaptive Auditive Cueing as a Therapy for Freezing of Gait in Parkinson Patients

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