Last updated on January 2020

Digital Wearable Walking Aid for Freezing of Gait in Parkinson s Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Parkinson's disease
  • Age: Between 40 - 90 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Clinical diagnosis of PD (n=31 per site) according to the recent criteria of the Movements Disorders Society
  • Modified Hoehn & Yahr (H&Y) Stage I to IV in the ON-state
  • Age between 40 and 90 years
  • Able to walk 5 minutes while unassisted by another person (The use of walking aids like a cane is allowed. The only exception is a rollator, which is an exclusion criterion).
  • MMSE >= 21 or > 16 on the MMSE telephone screen
  • Stable PD medications (no change in past month) and ensuring sufficient stable testing time.
  • New Freezing of gait questionnaire score >1 and clinically observed FOG.

Exclusion Criteria:

  • Participation in another clinical study
  • Already using a cueing device on a routine basis.
  • Excessively high fall risk, i.e. a fall frequency of more than once a day; this precaution is taken to make sure that no patients will be at high risk during the study.
  • Acute musculoskeletal or other neurological or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent the participant from completing the protocol in full.
  • Severe hearing problems precluding use of auditory feedback from the DeFOG system.
  • Unable to adhere to interventions and/or assessment procedures
  • Occurrence of any of the following within 3 months prior to informed consent:
  • Orthopedic surgery of the lower extremity
  • Myocardial infarction
  • Hospitalization for unstable angina
  • Coronary artery bypass graft
  • Percutaneous coronary intervention
  • Implantation of a cardiac resynchronization therapy device
  • Implantation of deep brain stimulation
  • Substance abuse that may interfere with the patient's compliance
  • Major depressive disorder or clinical apathy that precludes daily walking activity

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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