Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease

Background: Freezing of gait (FOG) is a highly incapacitating symptom that affects many people with Parkinson's disease (PD). Cueing triggered upon real-time FOG detection (on-demand cueing) shows promise for FOG treatment. Yet, the feasibility of implementation and efficacy in daily life is st...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Demi Zoetewei, Talia Herman, Marina Brozgol, Pieter Ginis, Pablo Cornejo Thumm, Eva Ceulemans, Eva Decaluwé, Luca Palmerini, Alberto Ferrari, Alice Nieuwboer, Jeffrey M. Hausdorff
Formato: article
Lenguaje:EN
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://doaj.org/article/8f172de2b343418d925e0bd698454f08
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:8f172de2b343418d925e0bd698454f08
record_format dspace
spelling oai:doaj.org-article:8f172de2b343418d925e0bd698454f082021-11-10T04:30:15ZProtocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease2451-865410.1016/j.conctc.2021.100817https://doaj.org/article/8f172de2b343418d925e0bd698454f082021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001186https://doaj.org/toc/2451-8654Background: Freezing of gait (FOG) is a highly incapacitating symptom that affects many people with Parkinson's disease (PD). Cueing triggered upon real-time FOG detection (on-demand cueing) shows promise for FOG treatment. Yet, the feasibility of implementation and efficacy in daily life is still unknown. Therefore, this study aims to investigate the effectiveness of DeFOG: a smartphone and sensor-based on-demand cueing solution for FOG. Methods: Sixty-two PD patients with FOG will be recruited for this single-blind, multi-center, randomized controlled phase II trial. Patients will be randomized into either the intervention group or the active control group. For four weeks, both groups will receive feedback about their physical activity using the wearable DeFOG system in daily life. In addition, the intervention group will also receive on-demand auditory cueing and instructions. Before and after the intervention, home-based assessments will be performed to evaluate the primary outcome, i.e., “percentage time frozen” during a FOG-provoking protocol. Secondary outcomes include the training effects on physical activity monitored over 7 days and the user-friendliness of the technology. Discussion: The DeFOG trial will investigate the effectiveness of personalized on-demand cueing in a controlled design, delivered for 4 weeks in the patient's home environment. We anticipate that DeFOG will reduce FOG to a greater degree than in the control group and we will explore the impact of the intervention on physical activity levels. We expect to gain in-depth insight into whether and how patients control FOG using cueing methods in their daily lives. Trial registration: Clinicaltrials.gov NCT03978507.Demi ZoeteweiTalia HermanMarina BrozgolPieter GinisPablo Cornejo ThummEva CeulemansEva DecaluwéLuca PalmeriniAlberto FerrariAlice NieuwboerJeffrey M. HausdorffElsevierarticleParkinson's diseaseFreezing of gaitDetection of freezing of gaitOn-demand cueingHome environmentMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100817- (2021)
institution DOAJ
collection DOAJ
language EN
topic Parkinson's disease
Freezing of gait
Detection of freezing of gait
On-demand cueing
Home environment
Medicine (General)
R5-920
spellingShingle Parkinson's disease
Freezing of gait
Detection of freezing of gait
On-demand cueing
Home environment
Medicine (General)
R5-920
Demi Zoetewei
Talia Herman
Marina Brozgol
Pieter Ginis
Pablo Cornejo Thumm
Eva Ceulemans
Eva Decaluwé
Luca Palmerini
Alberto Ferrari
Alice Nieuwboer
Jeffrey M. Hausdorff
Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
description Background: Freezing of gait (FOG) is a highly incapacitating symptom that affects many people with Parkinson's disease (PD). Cueing triggered upon real-time FOG detection (on-demand cueing) shows promise for FOG treatment. Yet, the feasibility of implementation and efficacy in daily life is still unknown. Therefore, this study aims to investigate the effectiveness of DeFOG: a smartphone and sensor-based on-demand cueing solution for FOG. Methods: Sixty-two PD patients with FOG will be recruited for this single-blind, multi-center, randomized controlled phase II trial. Patients will be randomized into either the intervention group or the active control group. For four weeks, both groups will receive feedback about their physical activity using the wearable DeFOG system in daily life. In addition, the intervention group will also receive on-demand auditory cueing and instructions. Before and after the intervention, home-based assessments will be performed to evaluate the primary outcome, i.e., “percentage time frozen” during a FOG-provoking protocol. Secondary outcomes include the training effects on physical activity monitored over 7 days and the user-friendliness of the technology. Discussion: The DeFOG trial will investigate the effectiveness of personalized on-demand cueing in a controlled design, delivered for 4 weeks in the patient's home environment. We anticipate that DeFOG will reduce FOG to a greater degree than in the control group and we will explore the impact of the intervention on physical activity levels. We expect to gain in-depth insight into whether and how patients control FOG using cueing methods in their daily lives. Trial registration: Clinicaltrials.gov NCT03978507.
format article
author Demi Zoetewei
Talia Herman
Marina Brozgol
Pieter Ginis
Pablo Cornejo Thumm
Eva Ceulemans
Eva Decaluwé
Luca Palmerini
Alberto Ferrari
Alice Nieuwboer
Jeffrey M. Hausdorff
author_facet Demi Zoetewei
Talia Herman
Marina Brozgol
Pieter Ginis
Pablo Cornejo Thumm
Eva Ceulemans
Eva Decaluwé
Luca Palmerini
Alberto Ferrari
Alice Nieuwboer
Jeffrey M. Hausdorff
author_sort Demi Zoetewei
title Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
title_short Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
title_full Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
title_fullStr Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
title_full_unstemmed Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
title_sort protocol for the defog trial: a randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in parkinson's disease
publisher Elsevier
publishDate 2021
url https://doaj.org/article/8f172de2b343418d925e0bd698454f08
work_keys_str_mv AT demizoetewei protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT taliaherman protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT marinabrozgol protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT pieterginis protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT pablocornejothumm protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT evaceulemans protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT evadecaluwe protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT lucapalmerini protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT albertoferrari protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT alicenieuwboer protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
AT jeffreymhausdorff protocolforthedefogtrialarandomizedcontrolledtrialontheeffectsofsmartphonebasedondemandcueingforfreezingofgaitinparkinsonsdisease
_version_ 1718440672816529408