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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Freezing of Gait
• Intervention / Treatment: Device: Tactile Cueing Device

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raoul Schweinfurther, M.A.; Phone Number: +41 71 424 3118; Email: r.schweinfurther@rehaklinik-zihlschlacht.ch
• Study Contact Backup: Name: Carsten Möller, Prof.; Phone Number: +41 71 424 3021; Email: C.Moeller@rehaklinik-zihlschlacht.ch

Study Locations

• Switzerland
  • Thurgau
    • Zihlschlacht, Thurgau, Switzerland, 8588
      • Recruiting
      • Rehaklinik Zihlschlacht AG
      • Contact: Raoul Schweinfurther, M.A. Sport Science; Phone Number: +41 71 424 3118; Email: R.Schweinfurther@rehaklinik-zihlschlacht.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Using the Tactile Cueing Device

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Rehaklinik Zihlschlacht AG
• Investigators: Principal Investigator: Raoul Schweinfurther, M.A., Rehaklinik Zihlschlacht AG

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: RZS_01_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No