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

Not Applicable

Recruiting

• Conditions: Parkinson Disease; Freezing of Gait
• Interventions: Device: Tactile Cueing Device

• Registration Number: NCT04459559
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-07
• Study Start: 2020-11-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Tactile Cueing Device	Using the Tactile Cueing Device

Primary Outcome Measures

Name	Time	Method
Usability	2 weeks	Usability of the cueing device is measured by a self-developed questionnaire.
Acceptance	2 weeks	Acceptance is measured by a self-developed questionnaire.
Frequency using the device	2 weeks	How often the device is used (counts logging protocol).
System Usability Scale	2 weeks	Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
Setup cueing device	2 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rehaklinik Zihlschlacht AG; 🇨🇭 Zihlschlacht, Thurgau, Switzerland