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Parkinson DiseaseNCT03978507

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

A study testing Intelligent cueing and Feedback about the number of steps in people with Parkinson Disease, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Parkinson Disease
What is being tested?
Intelligent cueing and Feedback about the number of steps
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesin 2 countries
Study dates
13 Jun 2019to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Catholic University (KU) Leuven

    Leuven, Flamish-Brabant, 3001

Other trials in Belgium

Israel1 site

  • Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC

    Tel Aviv, IL, 64239

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Intelligent cueing, Feedback about the number of steps
Keywords
Freezing of Gait, Intelligent external cueing systems, Free living gait monitoring, Patient-Adaptive Freezing of Gait Detection System
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intelligent cueingBehavioural

    1 month use of an intelligent, wearable device that provides personalized cueing only when FOG is detected

  • Feedback about the number of stepsBehavioural

    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.

Study groups in NCT03978507
Study groupRoleWhat they receive
DeFOG groupExperimentalfeedback number of steps + cueing
Receives: Behavioral: Intelligent cueing; Behavioral: Feedback about the number of steps
Control groupActive comparatorfeedback number of steps
Receives: Behavioral: Feedback about the number of steps

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: immediate post-intervention

Secondary outcomes (9)

  1. 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.

    Measured: immediate post-intervention

  2. 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.

    Measured: immediate post-intervention

  3. 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).

    Measured: immediate post-intervention

  4. 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).

    Measured: immediate post-intervention

  5. 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).

    Measured: One week post-intervention

  6. 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).

    Measured: immediate post-intervention

  7. 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).

    Measured: immediate post-intervention

  8. 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.

    Measured: immediate post-intervention

  9. 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.

    Measured: immediate post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start13 Jun 2019
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03978507
Sponsor's protocol ID
TASMC-18-NG-0908-18-TLV-CTIL
Status last verified
Jan 2021
First submitted
6 Jun 2019
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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.

    PubMed 28855887

  • 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.

    PubMed 26259206

  • 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.

    PubMed 26777408

  • 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.

    PubMed 30871253

  • 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.

    PubMed 31046191

  • Denk D, Herman T, Zoetewei D, Ginis P, Brozgol M, Cornejo Thumm P, Decaluwe E, Ganz N, Palmerini L, Giladi N, Nieuwboer A, Hausdorff JM. Daily-Living Freezing of Gait as Quantified Using Wearables in People With Parkinson Disease: Comparison With Self-Report and Provocation Tests. Phys Ther. 2022 Dec 6;102(12):pzac129. doi: 10.1093/ptj/pzac129.

    PubMed 36179090

  • 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.

    PubMed 34816053

Questions about this trial

What is this clinical trial studying?

A study testing Intelligent cueing and Feedback about the number of steps in people with Parkinson Disease, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in severity of the freezing of gait phenomenon: percentage time frozen (%TF) (time frame: immediate post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03978507, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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