Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease
November 23, 2023 updated by: Tel-Aviv Sourasky Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DeFOG group
feedback number of steps + cueing
|
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.
|
|
Active Comparator: Control group
feedback number of steps
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in severity of the freezing of gait phenomenon: percentage time frozen (%TF)
Time Frame: immediate post-intervention
|
%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
Time Frame: immediate post-intervention
|
%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
Time Frame: immediate post-intervention
|
%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)
Time Frame: immediate post-intervention
|
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).
Time Frame: immediate post-intervention
|
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.
Time Frame: One week post-intervention
|
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)
Time Frame: immediate post-intervention
|
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)
Time Frame: immediate post-intervention
|
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
Time Frame: immediate post-intervention
|
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
Time Frame: immediate post-intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jeffrey M Hausdorff, PhD, Tel-Aviv Sourasky Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2019
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
June 6, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-18-NG-0908-18-TLV-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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