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

Parkinson Disease Clinical Trial

— TCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459559
• Other study ID #: RZS_01_2020
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Swiss Federal Institute of Technology
• Contact: Raoul Schweinfurther, M.A.
• Phone: +41 71 424 3118
• Email: r.schweinfurther[@]rehaklinik-zihlschlacht.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Rehaklinik Zihlschlacht AG	Zihlschlacht	Thurgau

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Rehaklinik Zihlschlacht AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10. — View Citation

Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7. — View Citation

Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	System Usability Scale	Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').	2 weeks
Primary	Usability	Usability of the cueing device is measured by a self-developed questionnaire.	2 weeks
Primary	Acceptance	Acceptance is measured by a self-developed questionnaire.	2 weeks
Primary	Frequency using the device	How often the device is used (counts logging protocol).	2 weeks
Secondary	Walking speed [meters/second]	Calculated by the assessments 10 meter walk test and 2-minute walk test.	1 week
Secondary	Cadence [steps/minute]	Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).	1 week
Secondary	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
Secondary	Step length right/left [in meters]	Measured by a system of movement analysis (C-Mill MOTEK).	1 week
Secondary	Initial step latency [in seconds]	Extracted from video documentation by a blinded rater.	1 week
Secondary	Number of FOG	Extracted from video documentation by a blinded rater.	1 week