APPLICABILITY OF A NEW TACTILE CUEING DEVICE FOR PARKINSON'S PATIENTS
Zusammenfassung der Studie
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)
Untersuchte Intervention
Applicability of a novel cueing device in a clinical setting.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Andere
(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)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Raoul Schweinfurther
+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.chRehaklinik Zihlschlacht AG, Hauptstr. 2-4, CH-8588 Zihlschlacht
(BASEC)
Allgemeine Auskünfte
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Wissenschaftliche Auskünfte
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
27.08.2020
(BASEC)
ICTRP Studien-ID
NCT04459559 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Usability study of a novel tactile cueing device for patients with Parkinson’s disease: A monocentric interventional study (BASEC)
Wissenschaftlicher Titel
Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study (ICTRP)
Öffentlicher Titel
Usability of a Novel Cueing Device for Patients With Parkinson's Disease (ICTRP)
Untersuchte Krankheit(en)
Freezing of Gait;Parkinson Disease (ICTRP)
Untersuchte Intervention
Device: Tactile Cueing Device (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Rehaklinik Zihlschlacht AG (ICTRP)
Weitere Kontakte
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)
Sekundäre IDs
RZS_01_2020 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04459559 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar