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

NCT04459559 | Unknown

• 1 other identifier: RZS_01_2020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Freezing of Gait; Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Walking speed [meters/second]

  1 week

• Cadence [steps/minute]

  1 week

• Walking distance [in meters]

  1 week

• Step length right/left [in meters]

  1 week

• Initial step latency [in seconds]

  1 week

Study Arms (1)

Intervention

EXPERIMENTAL

Using the Tactile Cueing Device

Device: Tactile Cueing Device

Interventions

Tactile Cueing Device 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Rehaklinik Zihlschlacht AG: collaborator

Study Sites (1)

Rehaklinik Zihlschlacht AG

Zihlschlacht, Thurgau, 8588, Switzerland

RECRUITING

Related 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.

  PMID: 19906597 BACKGROUND

• 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.

  PMID: 17988925 BACKGROUND

• 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.

  PMID: 18668629 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Raoul Schweinfurther, M.A.

  Rehaklinik Zihlschlacht AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul Schweinfurther, M.A.

CONTACT

+41 71 424 3118; r.schweinfurther@rehaklinik-zihlschlacht.ch

Carsten Möller, Prof.

CONTACT

+41 71 424 3021; C.Moeller@rehaklinik-zihlschlacht.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: July 7, 2020
• Study Start: November 16, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)