APPLICABILITY OF A NEW TACTILE CUEING DEVICE FOR PARKINSON'S PATIENTS
Résumé de l'étude
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 étudiée
Applicability of a novel cueing device in a clinical setting.
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Autre
(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 pour plus d'informations sur l'étude
Personne de contact en Suisse
Raoul Schweinfurther
+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.chRehaklinik Zihlschlacht AG, Hauptstr. 2-4, CH-8588 Zihlschlacht
(BASEC)
Informations générales
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Informations scientifiques
Rehaklinik Zihlschlacht AG,
+41 71 424 3118;+41 71 424 3118
R.Schweinfurther@clutterrehaklinik-zihlschlacht.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date d'approbation du comité d'éthique
27.08.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04459559 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Usability study of a novel tactile cueing device for patients with Parkinson’s disease: A monocentric interventional study (BASEC)
Titre académique
Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study (ICTRP)
Titre public
Usability of a Novel Cueing Device for Patients With Parkinson's Disease (ICTRP)
Maladie en cours d'investigation
Freezing of Gait;Parkinson Disease (ICTRP)
Intervention étudiée
Device: Tactile Cueing Device (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Rehaklinik Zihlschlacht AG (ICTRP)
Contacts supplémentaires
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 secondaires
RZS_01_2020 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04459559 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible