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

Study Overview
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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).

Official Title
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Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study

Conditions
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Freezing of Gait, Parkinson Disease

Intervention / Treatment
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* Device: Tactile Cueing Device


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Using the Tactile Cueing Device | Device: Tactile Cueing Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Setup cueing device | Time needed for the setup [in seconds] and the variations of the different setup parameters (cueing length [seconds], cueing strength [% of maximum], cueing cadence [count/minutes]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage. | 2 weeks | 
| System Usability Scale | Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree'). | 2 weeks | 
| Usability | Usability of the cueing device is measured by a self-developed questionnaire. | 2 weeks | 
| Acceptance | Acceptance is measured by a self-developed questionnaire. | 2 weeks | 
| Frequency using the device | How often the device is used (counts logging protocol). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed [meters/second] | Calculated by the assessments 10 meter walk test and 2-minute walk test. | 1 week | 
| Cadence [steps/minute] | Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK). | 1 week | 
| Walking distance [in meters] | Measured by a digital measuring wheel during 2-minute walk test. Also measured by a system of movement analysis (C-Mill MOTEK). | 1 week | 
| Step length right/left [in meters] | Measured by a system of movement analysis (C-Mill MOTEK). | 1 week | 
| Initial step latency [in seconds] | Extracted from video documentation by a blinded rater. | 1 week | 
| Number of FOG | Extracted from video documentation by a blinded rater. | 1 week |