Status:

RECRUITING

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

Lead Sponsor:

Swiss Federal Institute of Technology

Collaborating Sponsors:

Rehaklinik Zihlschlacht AG

Conditions:

Freezing of Gait

Parkinson Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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....

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

November 16 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04459559

Start Date

November 16 2020

End Date

December 31 2024

Last Update

January 12 2024

Active Locations (1)

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Rehaklinik Zihlschlacht AG

Zihlschlacht, Thurgau, Switzerland, 8588