Evidence map›Paper›PMID 34816053›Full record

ArticleContemporary clinical trials communications2021

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 and 1 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03978507 nacompletednot on this map

Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease

TypeinterventionalSponsorTel-Aviv Sourasky Medical CenterRan2019 to 2023Enrolled62ConditionsParkinson DiseaseArmsIntelligent cueing, Feedback about the number of steps
NCT05718739 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Assessing and Understanding Freezing of Gait At-home Environment: FOG@Home

TypeinterventionalSponsorTel-Aviv Sourasky Medical CenterRan2023 to 2024Enrolled30ConditionsParkinson Disease, Freezing of GaitArmsAX6 6-axis logging accelerometer
NCT06204081 nacompletednot on this mapstarted 2023, after this paper: background citation

Exploration of the Short-term Effects and User Satisfaction of the Ceriter Stride One (CSO) Regarding the Prevention and Treatment of Freezing or Gait in Persons With Parkinson's Disease (pwP).

TypeinterventionalSponsorUniversity GhentRan2023 to 2024Enrolled11ConditionsGait, Festinating, Parkinson Disease, Device AdherenceArmsCSO_without cueing, CSO_cueing
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 4 countries.

Demi ZoeteweiKU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
Talia HermanCenter for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Marina BrozgolCenter for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Pieter GinisKU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
Pablo Cornejo ThummCenter for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Eva CeulemansKU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
Eva DecaluwéKU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
Luca PalmeriniDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi", University of Bologna, 40136, Bologna, Italy.
Alberto FerrariDepartment of Engineering "Enzo Ferrari" University of Modena and Reggio Emilia, Modena, Italy.
Alice NieuwboerKU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.
Jeffrey M HausdorffCenter for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
KU Leuven · BETel Aviv Sourasky Medical Center · ILFerrari (Italy) · ITMarconi University · ITTel Aviv University · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFreezing 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.

methodsSixty-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 registrationClinicaltrials.gov NCT03978507.

Indexed as

Detection of freezing of gaitFreezing of gaitHome environmentOn-demand cueingParkinson's disease

Identifiers

PMID34816053
PMCPMC8591418
OpenAlexW3176710273

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.