Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effects of relatively long-term use of a
      wearable device that provides personalized and intelligent cues (e.g. only when FOG is
      detected) on FOG.
    

Detailed description: 
      The objective of this study is to investigate the effects of relatively long-term use of a
      wearable device that provides personalized and intelligent cues (e.g. only when FOG is
      detected) on FOG. It is hypothesized that the use of this device will reduce FOG in the home
      and in the community more than in a group of freezers who only receive basic gait information
      unrelated to FOG-episodes.

      This study is a single- blinded bi-centric randomized controlled trial, consisting of 4 weeks
      of intervention, pre- and post- assessments and free-living monitoring. For this purpose, the
      DeFOG system was developed through a collaboration between our research group, the Sourasky
      Medical Center Tel Aviv and mHealth Technologies Bologna, Italy. The system consists of a
      smartphone, 2 foot-mounted inertial measurement units (IMU's) and earphones which enable
      transmitting feedback and auditory cues for gait, when FOG is about to occur. The patients
      will be randomized into an intervention group (DeFOG group) or a control group (N=31 per
      group). All patients will wear the DeFOG system (mHealth Technologies, mHT) and both groups
      will receive feedback about the daily number of steps produced. But, only the DeFOG group
      will receive cueing following detection of FOG. The cueing consists of a metronome, and if
      FOG persists, also a verbal instruction will be delivered. A therapist will personalize the
      settings of the DeFOG system and will support the patients in using the system (for instance
      in coping with false positives). Pre- and post- assessments will be performed by a blinded
      researcher, both before and after taking medication (in OFF and ON medication state,
      respectively), consisting of FOG-provoking tasks and questionnaires. During the
      post-assessment, the FOG provoking protocol will be repeated in both groups with and without
      the cueing option of the DeFOG system in the home situation.

      If therapists involved in the trial note an increase of falls throughout the trial, then it
      can be decided to involve an interim analysis of the data monitoring committee.
    

Intervention name(s): Intelligent cueing; Feedback about the number of steps
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1 month use of an intelligent, wearable device that provides personalized cueing only when FOG is detected; Feedback about the number of steps is given in the intervention group as well as in the control group during the 1-month intervention-period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an interventional study with a parallel design, consisting of pre- and post-assessments, 2x (pre- and post) 7 days of free-living gait monitoring and an intervention/control period of 4 weeks. The pre-assessment and first week of free-living gait monitoring will take place prior to randomization.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Freezing of Gait; Intelligent external cueing systems; Free living gait monitoring; Patient-Adaptive Freezing of Gait Detection System