Clinical trial NCT04274478: Adaptive Auditive Cueing As a Therapy for Freezing of Gait in Parkinson Patients
Official title: Biofeedback to Reduce Freezing of Gait in Parkinson Patients - Ceriter/Insole Parkinson Disease (IPD)-1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Ceriter Nederland BV
Sponsor class: INDUSTRY
Collaborators: name: Ziekenhuis Oost Limburg (ZOL) Hospital Genk, Belgium
First posted: 2020-02-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: The F1-score of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
timeFrame: 8 walks are performed in 1 hospital visit within 4 weeks of enrollment. Total assessment time estimate is 2x 30 minutes.
measure: The change in the number of FOG-episodes with and without AC
timeFrame: 1 week after the first hospital visit (for Outcome 1).
measure: The change in the total duration of FOG-episodes with and without AC
timeFrame: within 1 to 3 weeks after the first hospital visit
Secondary outcomes:
measure: The sensitivity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
timeFrame: Within 4 weeks of enrollment
measure: The specificity of FOG detection from the measured and classified (normal walk vs FOG) gait data compared to manually scored recorded video.
timeFrame: within 1 to 3 weeks after the first hospital visit
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: ZOL Genk
name: An Driesen, MD, Neurologist
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.