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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Intelligent cueing
* Behavioral: Feedback about the number of steps


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical diagnosis of Parkinson's disease (PD) (n=31 per site) according to the UK PD Society Brain Bank criteria Modified Hoehn & Yahr Stage I to IV in the ON-state; Age between 40 and 90 years; Ability to walk 5 minutes while unassisted by another person; Mini-Mental State Examination (MMSE) score of >= 21 or > 16 on the 26-item MMSE screening; Stable PD medication during the previous month and no medication change foreseen for the next 6 weeks. Self-reported freezing of gait (FOG) severity of at least 1 FOG episode per day, based on Characterizing of Freezing of Gait Questionnaire, irrespective of FOG occurring ON- or OFF-medication. Exclusion criteria: Participation in another clinical study; Use of a cueing device as normal practice; A fall frequency of more than once a day; Acute musculoskeletal or other neurological or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent completing the protocol; Hearing problems, precluding use of auditory feedback from the DeFOG system; The 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, major depressive disorder or clinical apathy that affects daily walking activity or may interfere with the patient's compliance; Inability to walk without a rollator indoors; Use of a Duodopa® or apomorphine injections, jeopardizing OFF-medication assessments; Absence of clinically observed FOG during the FOG-provoking assessment at the pre-intervention assessment (T1).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DeFOG group<br>feedback number of steps + cueing | Behavioral: Intelligent cueing<br>* 1 month use of an intelligent, wearable device that provides personalized cueing only when FOG is detected<br>Behavioral: Feedback about the number of steps<br>* 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.<br>|
| Active Comparator: Control group<br>feedback number of steps | Behavioral: Feedback about the number of steps<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of the freezing of gait phenomenon: percentage time frozen (%TF) | %TF is determined based on video annotations of the full FOG-provoking protocol (OFF+ON) during the pre- and post-intervention assessment (T1 and T2). %TF = (summed duration FOG during FOG-provoking protocol ON+OFF)/(total duration FOG-provoking protocol OFF+ON)*100%. Freezing includes episodes of akinetic FOG, trembling FOG and festination. | immediate post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of the freezing of gait phenomenon: %TF OFF medication | %TF is determined based on video annotations of the OFF-phase of the FOG-provoking protocol during the pre- and post-intervention assessment (T1 and T2). %TF = (summed duration FOG during FOG-provoking protocol OFF)/(total duration FOG-provoking protocol OFF)*100%. Freezing includes episodes of akinetic FOG, trembling FOG and festination. | immediate post-intervention | 
| Changes in severity of the freezing of gait phenomenon: %TF ON medication | %TF is determined based on video annotations of the ON-phase of the FOG-provoking protocol during the pre- and post-intervention assessment (T1 and T2). %TF = (summed duration FOG during FOG-provoking protocol ON)/(total duration FOG-provoking protocol ON)*100%. Freezing includes episodes of akinetic FOG, trembling FOG and festination. | immediate post-intervention | 
| Change in number and duration of FOG episodes (video-based) | The number and duration of FOG episodes as determined based on annotations of video recordings of the FOG-provoking protocol, both OFF and ON medication, during the pre- and post-intervention assessment (T1 and T2). | immediate post-intervention | 
| Changes in severity of the freezing of gait phenomenon (subjective measurement): score on new Freezing of Gait questionnaire (NFOG-Q). | The change in the score on the New Freezing of Gait questionnaire (NFOG-Q), which is the revised version of the original Freezing of Gait Questionnaire. The NFOG-Q consists of 9 items, and the maximum score is 28. Higher scores correspond to more severe perceived FOG. The NFOG-Q is administered during the pre- and post-intervention assessments (T1 and T2). | immediate post-intervention | 
| Changes in physical activity, as recorded using an accelerometer placed on the lower back. | Physical activity will be determined based on recordings using an accelerometer placed on the lower back for 7 days (Axivity; AX3: 3-Axis Logging Accelerometer or AX6: 6-Axis Logging Accelerometer). Outcome measures include the number of steps, the number of bouts of physical activity and the duration of bouts of physical activity. The Axivity sensor is placed before the start of the pre- and post intervention assessment (T1 and T2) and will record continuously for 7 days (during the monitoring weeks). | One week post-intervention | 
| Changes in Timed Up and Go (TUG) test Performance (sec) | Change in the duration to perform the Timed-Up and Go (TUG) test in seconds, with and without a cognitive dual task (serial-3 subtraction), both OFF- and ON-medication. The Timed Up and Go performance is a measure of mobility, and a longer duration to perform the task represents a more impaired mobility. The TUG test is administered as part of the FOG-provoking protocol, during the pre- and post-intervention assessments (T1 and T2). | immediate post-intervention | 
| Changes in 4 meter walk test (4MW) performance (sec) | Change in the duration to walk 4 meters (in seconds), both OFF- and ON-medication. The full 4 meter walk test (4MW) back and forth with turn consists of 5 meters (0.5 meter acceleration, 4 meter steady state walking, 0.5 meter deceleration, a turn on the spot, and then again 0.5 meter acceleration, 4 meter steady state walking and 0.5 meter deceleration). The duration to walk 4 meters before and after the turn will be determined based on video annotations and averaged. The 4MW is administered as part of the FOG-provoking protocol, during the pre- and post-intervention assessments (T1 and T2). | immediate post-intervention | 
| Change in motor function: score on the MDS-UPDRS part III | Score on the Motor Examination (part III) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), assessed both OFF and ON-medication during the pre- and post-intervention assessments (T1 and T2). MDS-UPDRS is a tool to measure the severity and progression of Parkinson disease (PD). Part III is a motor examination consisting of 14 items, each rated on a 5-point Likert type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum UPDRS part III score is 132, with higher score representing worse motor disability from PD. | immediate post-intervention | 
| Change in balance: score on the MiniBESTest | Change in score on the Mini-Balance Evaluation Systems Test (MiniBESTest), as assessed during the pre- and post-intervention assessment while ON-medication. The MiniBESTest consists of 14 items designed to measure balance performance during mobility tasks related to daily activities. Each item receives a score of 0 to 2, where a score of 0 represents an inability to complete the item and a score of 2 represents the ability to complete the task independently. The range of scores is 0-28, with a higher score representing worse balance impairments. | immediate post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Freezing of Gait, Intelligent external cueing systems, Free living gait monitoring, Patient-Adaptive Freezing of Gait Detection System