TY - JOUR
T1 - Protocol for the DeFOG trial
T2 - A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease
AU - Zoetewei, Demi
AU - Herman, Talia
AU - Brozgol, Marina
AU - Ginis, Pieter
AU - Thumm, Pablo Cornejo
AU - Ceulemans, Eva
AU - Decaluwé, Eva
AU - Palmerini, Luca
AU - Ferrari, Alberto
AU - Nieuwboer, Alice
AU - Hausdorff, Jeffrey M.
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Detection of freezing of gait
KW - Freezing of gait
KW - Home environment
KW - On-demand cueing
KW - Parkinson's disease
UR - http://www.scopus.com/inward/record.url?scp=85118857554&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2021.100817
DO - 10.1016/j.conctc.2021.100817
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C2 - 34816053
AN - SCOPUS:85118857554
SN - 2451-8654
VL - 24
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100817
ER -