APPLICABILITY OF A NEW TACTILE CUEING DEVICE FOR PARKINSON'S PATIENTS
Descrizione riassuntiva dello studio
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)
Intervento studiato
Applicability of a novel cueing device in a clinical setting.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Altro
(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)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Raoul Schweinfurther
+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.chRehaklinik Zihlschlacht AG, Hauptstr. 2-4, CH-8588 Zihlschlacht
(BASEC)
Informazioni generali
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Informazioni scientifiche
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
27.08.2020
(BASEC)
ID di studio ICTRP
NCT04459559 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Usability study of a novel tactile cueing device for patients with Parkinson’s disease: A monocentric interventional study (BASEC)
Titolo accademico
Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study (ICTRP)
Titolo pubblico
Usability of a Novel Cueing Device for Patients With Parkinson's Disease (ICTRP)
Malattie studiate
Freezing of Gait;Parkinson Disease (ICTRP)
Intervento studiato
Device: Tactile Cueing Device (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Rehaklinik Zihlschlacht AG (ICTRP)
Contatti aggiuntivi
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)
ID secondari
RZS_01_2020 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04459559 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile