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

NCT03978507 | Completed DMC

• 1 other identifier: TASMC-18-NG-0908-18-TLV-CTIL
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Freezing of Gait; Intelligent external cueing systems; Free living gait monitoring; Patient-Adaptive Freezing of Gait Detection System

Outcome Measures

Primary Outcomes (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.

  immediate post-intervention

Secondary Outcomes (9)

• Changes in severity of the freezing of gait phenomenon: %TF OFF medication

  immediate post-intervention

• Changes in severity of the freezing of gait phenomenon: %TF ON medication

  immediate post-intervention

• Change in number and duration of FOG episodes (video-based)

  immediate post-intervention

• Changes in severity of the freezing of gait phenomenon (subjective measurement): score on new Freezing of Gait questionnaire (NFOG-Q).

  immediate post-intervention

• Changes in physical activity, as recorded using an accelerometer placed on the lower back.

  One week post-intervention

Study Arms (2)

DeFOG group

EXPERIMENTAL

feedback number of steps + cueing

Behavioral: Intelligent cueing; Behavioral: Feedback about the number of steps

Control group

ACTIVE COMPARATOR

feedback number of steps

Behavioral: Feedback about the number of steps

Interventions

Intelligent cueing BEHAVIORAL

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

DeFOG group

Feedback about the number of steps BEHAVIORAL

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.

Control group; DeFOG group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• KU Leuven: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (2)

Catholic University (KU) Leuven

Leuven, Flamish-Brabant, 3001, Belgium

Location

Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC

Tel Aviv, IL, 64239, Israel

Location

Related Publications (7)

• 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.

  PMID: 28855887 BACKGROUND

• 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.

  PMID: 26259206 BACKGROUND

• 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.

  PMID: 26777408 BACKGROUND

• 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.

  PMID: 30871253 BACKGROUND

• 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.

  PMID: 31046191 BACKGROUND

• 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.

  PMID: 36179090 DERIVED

• 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.

  PMID: 34816053 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jeffrey M Hausdorff, PhD

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Prior to randomization, all participants will be informed that the goal of the study is to compare the effects of two types of feedback about physical activity on freezing of gait. By withholding information about the cueing intervention, we hope that the participants in the control group will not realize that they are in the control group, in order to avoid a lack of motivation in this group. The intervention group will probably become unmasked after group allocation, as the cueing therapy was not mentioned in the informed consent. During the post-assessment, the FOG provoking protocol will be performed with and without cueing. This induces the risk of the investigator/outcome assessor becoming unmasked, as patients in the control group may mention that this cueing option is something they haven't experienced during the intervention period. In order to prevent this, the therapist will ask patients in the intervention group to also act surprised to the cueing modality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 7, 2019
• Study Start: June 13, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 27, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

IL (1); BE (1)