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

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 .

Dual Task Turning in Place: A Reliable, Valid, and Responsive Outcome Measure of Freezing of Gait

“…Thus, although we do not directly compare these approaches, here we provide evidence that using a high‐specificity approach provides reliable and valid FOG outcomes. Future work may apply a weighting approach to integrate the various FOG‐spectrum presentations, similar to those used in clinical scoring tools 22,41,42 . In addition, testing these methods and criteria in a larger sample of raters from multiple institutions may provide more robust reliability estimates and lead to further refinement and validation of this approach.…”

Daily-Living Freezing of Gait as Quantified Using Wearables in People With Parkinson Disease: Comparison With Self-Report and Provocation Tests

“… Supervised, in-home tasks provoking freezing of gait (FOG) while off and on dopaminergic medication. 27 DT = dual task; ST = single task. …”

“…1 ) consists of 5 different tests that were carried out in each participant’s home and were adapted and modified from the test originally proposed by Ziegler et al 18 This home-based protocol included a 4-m walk test, back and forth, to measure gait speed and cadence; the Timed “Up & Go” Test, performed in a single-task condition and in a serial-3-subtraction dual-task condition; a turning task, which involved a full 360-degree turn in place, repeated 4 times, with alternating directions in single- and dual-task conditions; walking through narrow-space passages, for which participants were asked to walk 2 m, open a door, pass through the doorway, turn in place, and return to the starting point, typically a bathroom or a toilet; and a personal hot spot, a self-reported area where a participant often experienced FOG. 27 The participants were evaluated while off and on dopaminergic medication. Off-state performance was assessed following an overnight withdrawal of medication of at least 12 hours.…”

Technological support for people with Parkinson’s disease: a narrative review

“…In 2021 Zoetewei et al 61 presented on-demand cueing tools consisting of a smartphone, IMU sensors and headphones for the delivery of auditory cues. This work aimed at verify the effectiveness of the DeFOG system over four weeks in PD patients (n = 62) subjected to triggering FoG tests in order to collect data moments before these episodes.…”