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

Demi Zoetewei, Talia Herman, Marina Brozgol, Pieter Ginis, Pablo Cornejo Thumm, Eva Ceulemans, Eva Decaluwé, Luca Palmerini, Alberto Ferrari, Alice Nieuwboer, Jeffrey M Hausdorff, Demi Zoetewei, Talia Herman, Marina Brozgol, Pieter Ginis, Pablo Cornejo Thumm, Eva Ceulemans, Eva Decaluwé, Luca Palmerini, Alberto Ferrari, Alice Nieuwboer, Jeffrey M Hausdorff

Abstract

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.

Keywords: Detection of freezing of gait; Freezing of gait; Home environment; On-demand cueing; Parkinson's disease.

© 2021 The Authors.

Figures

Fig. 1
Fig. 1
Overview of the study design. PD: Parkinson's disease. FOG: freezing of gait. TASMC: Tel Aviv Sourasky Medical Center. KUL: KU Leuven. T1: baseline assessment. M1: baseline gait monitoring week. DeFOG group: intervention group. T2: post-intervention assessment. M2: post-intervention gait monitoring week.
Fig. 2
Fig. 2
An overview of the different tasks included in the FOG-provoking protocol. OFF-medication: without intake of Parkinsonian medication in the morning (at least 12 h). ON-medication: approximately 1 h after PD medication intake. T1: baseline assessment. T2: post-intervention assessment. NCUE: without cueing. CUE: with cueing. ST: single task. DT: dual task (serial-3 subtractions).
Fig. 3
Fig. 3
Concept of cue application in response to detection of a FOG episode. VI: verbal instruction. FOG: freezing of gait.
Fig. 4
Fig. 4
Device components of the DeFOG system. A: Smartphone showing the step count and the three sensors with Velcro straps to attach them to the feet and chest. B: The feet sensors attached to the shoes.

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