Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease
NCT ID: NCT03978507
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2019-06-13
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
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DeFOG group
feedback number of steps + cueing
Intelligent cueing
1 month use of an intelligent, wearable device that provides personalized cueing only when FOG is detected
Feedback about the 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.
Control group
feedback number of steps
Feedback about the 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.
Interventions
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Intelligent cueing
1 month use of an intelligent, wearable device that provides personalized cueing only when FOG is detected
Feedback about the 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.
Eligibility Criteria
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Inclusion 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
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).
40 Years
90 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Michael J. Fox Foundation for Parkinson's Research
OTHER
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Jeffrey M Hausdorff, PhD
Role: STUDY_CHAIR
Tel-Aviv Sourasky Medical Center
Locations
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Catholic University (KU) Leuven
Leuven, Flamish-Brabant, Belgium
Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC
Tel Aviv, IL, Israel
Countries
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References
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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.
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.
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.
Other Identifiers
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TASMC-18-NG-0908-18-TLV-CTIL
Identifier Type: -
Identifier Source: org_study_id