Usability of a Novel Cueing Device for Patients With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2024-12-31

Brief Summary

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Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).

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Detailed Description

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Conditions

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Freezing of Gait Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Using the Tactile Cueing Device

Group Type EXPERIMENTAL

Tactile Cueing Device

Intervention Type DEVICE

Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.

Interventions

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Tactile Cueing Device

Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
* Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.
* MoCA ≥ 22/30.
* Participant has signed the informed consent.

Exclusion Criteria

* Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
* Significantly, impaired cognitive skills render the participant unable to use the TCD.
* Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
* Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No