Clinical trial NCT04459559: Usability of a Novel Cueing Device for Patients With Parkinson's Disease
Official title: Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Freezing of Gait
Parkinson Disease
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Rehaklinik Zihlschlacht AG
First posted: 2020-07-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Setup cueing device
timeFrame: 2 weeks
measure: System Usability Scale
timeFrame: 2 weeks
measure: Usability
timeFrame: 2 weeks
measure: Acceptance
timeFrame: 2 weeks
measure: Frequency using the device
timeFrame: 2 weeks
Secondary outcomes:
measure: Walking speed [meters/second]
timeFrame: 1 week
measure: Cadence [steps/minute]
timeFrame: 1 week
measure: Walking distance [in meters]
timeFrame: 1 week
measure: Step length right/left [in meters]
timeFrame: 1 week
measure: Initial step latency [in seconds]
timeFrame: 1 week
measure: Number of FOG
timeFrame: 1 week
Other outcomes:
Locations:
city: Zihlschlacht
country: Switzerland
facility: Rehaklinik Zihlschlacht AG
state: Thurgau
Study officials:
affiliation: Rehaklinik Zihlschlacht AG
name: Raoul Schweinfurther, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.