APPLICABILITY OF A NEW TACTILE CUEING DEVICE FOR PARKINSON'S PATIENTS
Summary description of the study
This new development is a wearable technical aid. This so-called tactile cueing device is a small mobile pacemaker developed by the Sensory-Motor Systems Lab at ETH Zurich. The aid has already been tested under laboratory conditions and in the context of a so-called adaptation trial with Parkinson's patients, and is now being used for the first time in a clinical study on Parkinson's patients. The device is small enough to be worn comfortably on the wrist and thigh under clothing (see Figure 1 on the following page). When the aid is activated, it vibrates noticeably on your skin at the thigh. The vibration alternates between right and left and is set to match your normal walking speed.
(BASEC)
Intervention under investigation
Applicability of a novel cueing device in a clinical setting.
(BASEC)
Disease under investigation
Parkinson's Disease
(BASEC)
Adult patients who are severely affected by the symptoms of Parkinson's disease, such as hypokinesia (slow gait), festination (decreasing steps), and freezing of gait (motor rigidity or shuffling in place). (BASEC)
Exclusion criteria
Individuals with severe cognitive impairments and individuals who have such severe impairments that they can no longer walk independently. Skin injuries on the thigh or wrist that prevent the aid from being applied. (BASEC)
Trial sites
Other
(BASEC)
Zihlschlacht
(BASEC)
Sponsor
Prof. Dr. Dr. h.c. Robert Riener Labor für Sensomotorische Systeme Institut für Robotik und Intelligente Systeme IRIS Departement Gesundheitswissenschaften u. Technologie ETH Zurich, GLC G20.1 Gloriastrasse 37/39, CH-8092 Zurich Phone +41-44-632 49 31 riener@hest.ethz.ch http://www.sms.hest.ethz.ch
(BASEC)
Contact
Contact Person Switzerland
Raoul Schweinfurther
+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.chRehaklinik Zihlschlacht AG, Hauptstr. 2-4, CH-8588 Zihlschlacht
(BASEC)
General Information
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Scientific Information
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
27.08.2020
(BASEC)
ICTRP Trial ID
NCT04459559 (ICTRP)
Official title (approved by ethics committee)
Usability study of a novel tactile cueing device for patients with Parkinson’s disease: A monocentric interventional study (BASEC)
Academic title
Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study (ICTRP)
Public title
Usability of a Novel Cueing Device for Patients With Parkinson's Disease (ICTRP)
Disease under investigation
Freezing of Gait;Parkinson Disease (ICTRP)
Intervention under investigation
Device: Tactile Cueing Device (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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).
(ICTRP)
not available
Primary and secondary end points
Setup cueing device;System Usability Scale;Usability;Acceptance;Frequency using the device (ICTRP)
Walking speed [meters/second];Cadence [steps/minute];Walking distance [in meters];Step length right/left [in meters];Initial step latency [in seconds];Number of FOG (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Rehaklinik Zihlschlacht AG (ICTRP)
Additional contacts
Raoul Schweinfurther, M.A.;Raoul Schweinfurther, M.A.;Raoul Schweinfurther, M.A. Sport Science, r.schweinfurther@rehaklinik-zihlschlacht.ch; R.Schweinfurther@rehaklinik-zihlschlacht.ch, +41 71 424 3118;+41 71 424 3118, Rehaklinik Zihlschlacht AG, (ICTRP)
Secondary trial IDs
RZS_01_2020 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04459559 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available