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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.
Zoetewei, Demi; Herman, Talia; Brozgol, Marina; Ginis, Pieter; Thumm, Pablo Cornejo; Ceulemans, Eva; Decaluwé, Eva; Palmerini, Luca; Ferrari, Alberto; Nieuwboer, Alice; Hausdorff, Jeffrey M.
Afiliación
  • Zoetewei D; KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
  • Herman T; Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
  • Brozgol M; Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
  • Ginis P; KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
  • Thumm PC; Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
  • Ceulemans E; KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
  • Decaluwé E; KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
  • Palmerini L; Department of Electrical, Electronic, and Information Engineering "Guglielmo Marconi", University of Bologna, 40136, Bologna, Italy.
  • Ferrari A; Health Sciences and Technologies-Interdepartmental Center for Industrial Research (CIRI-SDV), University of Bologna, 40126, Bologna, Italy.
  • Nieuwboer A; Department of Engineering "Enzo Ferrari" University of Modena and Reggio Emilia, Modena, Italy.
  • Hausdorff JM; Science & Technology Park for Medicine, TPM, Democenter Foundation, Mirandola, Modena, Italy.
Contemp Clin Trials Commun ; 24: 100817, 2021 Dec.
Article en En | MEDLINE | ID: mdl-34816053
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Idioma: En Revista: Contemp Clin Trials Commun Año: 2021 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos
Texto completo
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Imprimir
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Idioma: En Revista: Contemp Clin Trials Commun Año: 2021 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos