Clinical trial NCT03978507: Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease
Official title: Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Freezing of Gait
Intelligent external cueing systems
Free living gait monitoring
Patient-Adaptive Freezing of Gait Detection System
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: KU Leuven
name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2019-06-07
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion criteria:

1. Clinical diagnosis of Parkinson's disease (PD) (n=31 per site) according to the UK PD Society Brain Bank criteria
2. Modified Hoehn \& Yahr Stage I to IV in the ON-state;
3. Age between 40 and 90 years;
4. Ability to walk 5 minutes while unassisted by another person;
5. Mini-Mental State Examination (MMSE) score of \>= 21 or \> 16 on the 26-item MMSE screening;
6. Stable PD medication during the previous month and no medication change foreseen for the next 6 weeks.
7. 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:

1. Participation in another clinical study;
2. Use of a cueing device as normal practice;
3. A fall frequency of more than once a day;
4. 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;
5. Hearing problems, precluding use of auditory feedback from the DeFOG system;
6. 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;
7. Substance abuse, major depressive disorder or clinical apathy that affects daily walking activity or may interfere with the patient's compliance;
8. Inability to walk without a rollator indoors;
9. Use of a Duodopa® or apomorphine injections, jeopardizing OFF-medication assessments;
10. Absence of clinically observed FOG during the FOG-provoking assessment at the pre-intervention assessment (T1).

Primary outcomes:
measure: Changes in severity of the freezing of gait phenomenon: percentage time frozen (%TF)
timeFrame: immediate post-intervention
Secondary outcomes:
measure: Changes in severity of the freezing of gait phenomenon: %TF OFF medication
timeFrame: immediate post-intervention
measure: Changes in severity of the freezing of gait phenomenon: %TF ON medication
timeFrame: immediate post-intervention
measure: Change in number and duration of FOG episodes (video-based)
timeFrame: immediate post-intervention
measure: Changes in severity of the freezing of gait phenomenon (subjective measurement): score on new Freezing of Gait questionnaire (NFOG-Q).
timeFrame: immediate post-intervention
measure: Changes in physical activity, as recorded using an accelerometer placed on the lower back.
timeFrame: One week post-intervention
measure: Changes in Timed Up and Go (TUG) test Performance (sec)
timeFrame: immediate post-intervention
measure: Changes in 4 meter walk test (4MW) performance (sec)
timeFrame: immediate post-intervention
measure: Change in motor function: score on the MDS-UPDRS part III
timeFrame: immediate post-intervention
measure: Change in balance: score on the MiniBESTest
timeFrame: immediate post-intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Catholic University (KU) Leuven
state: Flamish-Brabant
city: Tel Aviv
country: Israel
facility: Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC
state: IL
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Jeffrey M Hausdorff, PhD
role: STUDY_CHAIR
References:
citation: Palmerini L, Rocchi L, Mazilu S, Gazit E, Hausdorff JM, Chiari L. Identification of Characteristic Motor Patterns Preceding Freezing of Gait in Parkinson's Disease Using Wearable Sensors. Front Neurol. 2017 Aug 14;8:394. doi: 10.3389/fneur.2017.00394. eCollection 2017.
citation: Mazilu S, Calatroni A, Gazit E, Mirelman A, Hausdorff JM, Troster G. Prediction of Freezing of Gait in Parkinson's From Physiological Wearables: An Exploratory Study. IEEE J Biomed Health Inform. 2015 Nov;19(6):1843-54. doi: 10.1109/JBHI.2015.2465134. Epub 2015 Aug 5.
citation: Ginis P, Nieuwboer A, Dorfman M, Ferrari A, Gazit E, Canning CG, Rocchi L, Chiari L, Hausdorff JM, Mirelman A. Feasibility and effects of home-based smartphone-delivered automated feedback training for gait in people with Parkinson's disease: A pilot randomized controlled trial. Parkinsonism Relat Disord. 2016 Jan;22:28-34. doi: 10.1016/j.parkreldis.2015.11.004.
citation: Sweeney D, Quinlan LR, Browne P, Richardson M, Meskell P, OLaighin G. A Technological Review of Wearable Cueing Devices Addressing Freezing of Gait in Parkinson's Disease. Sensors (Basel). 2019 Mar 13;19(6):1277. doi: 10.3390/s19061277.
citation: Mancini M, Bloem BR, Horak FB, Lewis SJG, Nieuwboer A, Nonnekes J. Clinical and methodological challenges for assessing freezing of gait: Future perspectives. Mov Disord. 2019 Jun;34(6):783-790. doi: 10.1002/mds.27709. Epub 2019 May 2.
citation: Zoetewei D, Herman T, Brozgol M, Ginis P, Thumm PC, Ceulemans E, Decaluwe E, Palmerini L, Ferrari A, Nieuwboer A, Hausdorff JM. Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease. Contemp Clin Trials Commun. 2021 Jun 29;24:100817. doi: 10.1016/j.conctc.2021.100817. eCollection 2021 Dec.