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

2019-06-13 02:19:18 | BioPortfolio

Summary

The objective of this study is to investigate the effects of relatively long-term use of a wearable device that provides personalized and intelligent cues (e.g. only when FOG is detected) on FOG.

Description

The objective of this study is to investigate the effects of relatively long-term use of a wearable device that provides personalized and intelligent cues (e.g. only when FOG is detected) on FOG. It is hypothesized that the use of this device will reduce FOG in the home and in the community more than in a group of freezers who only receive basic gait information unrelated to FOG-episodes.

This study is a single- blinded bi-centric randomized controlled trial, consisting of 4 weeks of intervention, pre- and post- assessments and free-living monitoring. For this purpose, the DeFOG system was developed through a collaboration between our research group, the Sourasky Medical Center Tel Aviv and mHealth Technologies Bologna, Italy. The system consists of a smartphone, 2 foot-mounted inertial measurement units (IMU's) and earphones which enable transmitting feedback and auditory cues for gait, when FOG is about to occur. The patients will be randomized into an intervention group (DeFOG group) or a control group (N=31 per group). All patients will wear the DeFOG system (mHealth Technologies, mHT) and both groups will receive feedback about the daily number of steps produced. But, only the DeFOG group will receive cueing following detection of FOG. The cueing consists of a metronome, and if FOG persists, also a verbal instruction will be delivered. A therapist will personalize the settings of the DeFOG system and will support the patients in using the system (for instance in coping with false positives). Pre- and post- assessments will be performed by a blinded researcher, both before and after taking medication (in OFF and ON medication state, respectively), consisting of FOG-provoking tasks and questionnaires. During the post-assessment, the FOG provoking protocol will be repeated in both groups with and without the cueing option of the DeFOG system in the home situation.

Study Design

Conditions

Parkinson Disease

Intervention

Intelligent cueing, Feedback about the number of steps

Location

Catholic University (KU) Leuven
Leuven
Flamish-Brabant
Belgium
3001

Status

Recruiting

Source

Tel-Aviv Sourasky Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-06-13T02:19:18-0400

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Medical and Biotech [MESH] Definitions

Proteins associated with sporadic or familial cases of PARKINSON DISEASE.

A mechanism of communication with a physiological system for homeostasis, adaptation, etc. Physiological feedback is mediated through extensive feedback mechanisms that use physiological cues as feedback loop signals to control other systems.

A condition caused by the neurotoxin MPTP which causes selective destruction of nigrostriatal dopaminergic neurons. Clinical features include irreversible parkinsonian signs including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP toxicity is also used as an animal model for the study of PARKINSON DISEASE. (Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986 Feb;36(2):250-8)

A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.

Parkinsonism following encephalitis, historically seen as a sequella of encephalitis lethargica (Von Economo Encephalitis). The early age of onset, the rapid progression of symptoms followed by stabilization, and the presence of a variety of other neurological disorders (e.g., sociopathic behavior; TICS; MUSCLE SPASMS; oculogyric crises; hyperphagia; and bizarre movements) distinguish this condition from primary PARKINSON DISEASE. Pathologic features include neuronal loss and gliosis concentrated in the MESENCEPHALON; SUBTHALAMUS; and HYPOTHALAMUS. (From Adams et al., Principles of Neurology, 6th ed, p754)

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