Exploring a New Cueing Device in People Who Experience Freezing of Gait: Acceptance of a Study Design

Agnes Wilhelm, Tanja Riedl, Christian Paumann, Jessie Janssen, Agnes Wilhelm, Tanja Riedl, Christian Paumann, Jessie Janssen

Abstract

Background: Freezing of Gait (FoG) is a disabling symptom of Parkinson's Disease (PD) and is defined as a "brief episodic absence or marked reduction of forward progression of the feet despite the intention to walk." Compensatory strategies such as cueing and high frequency vibrotactile stimulation can reduce FoG severity and improve gait parameters. A new Sternal high frequency Vibrotactile Stimulation Device (SVSD) with cueing function has been developed, however the clinical effects of this device are yet to be fully investigated.

Objective: The aim of this study was to investigate, if the proposed study design using a SVSD and gait analysis sensor insoles was acceptable for people with PD.

Methods: This feasibility study was designed as a randomized cross-over study. Thirteen participants took part in a one off 60-minute data collection session. The acceptability of the study design was assessed with a mixed methods questionnaire considering each step of the study process. Secondary outcome measures were the feasibility of using the 10 Metre Walk Test (10MWT), the Freezing of Gait Score (FoG-Score), and Patient Global Impression of Change (PGI-C) with and without the SVSD.

Results: The participants scored all aspects of the study design as very satisfactory. In addition, all participants could perform the secondary outcome measures and were deemed feasible. Feedback from open ended questions provided ideas and considerations for adaptations of future clinical studies.

Conclusion: The proposed study design was acceptable for people with PD. Implications. This study design, with small adaptations, can be used for larger studies to evaluate the effect of an SVSD on FoG in people with PD.

Conflict of interest statement

The authors declare that there are no conflicts of interest regarding the publication of this paper.

Copyright © 2022 Agnes Wilhelm et al.

Figures

Figure 1
Figure 1
Application of the SVSD and gait analysis sensor insoles.
Figure 2
Figure 2
CONSORT flow diagram on enrolment, allocation, and analysis.

References

    1. Hayes M. T. Parkinson’s disease and parkinsonism. The American Journal of Medicine . 2019;132(7):802–807. doi: 10.1016/j.amjmed.2019.03.001.
    1. Gao C., Liu J., Tan Y., Chen S. Freezing of gait in Parkinson’s disease: pathophysiology, risk factors and treatments. Translational Neurodegeneration . 2020;9(1):p. 12. doi: 10.1186/s40035-020-00191-5.
    1. Walton C. C., Shine J. M., Hall J. M., et al. The major impact of freezing of gait on quality of life in Parkinson’s disease. Journal of Neurology . 2015;262(1):108–115. doi: 10.1007/s00415-014-7524-3.
    1. Ginis P., Nackaerts E., Nieuwboer A., Heremans E. Cueing for people with Parkinson’s disease with freezing of gait: a narrative review of the state-of-the-art and novel perspectives. Annals of Physical and Rehabilitation Medicine . 2018;61(6):407–413. doi: 10.1016/j.rehab.2017.08.002.
    1. Mosabbir A., Almeida Q. J., Ahonen H. The effects of long-term40-hz physioacoustic vibrations on motor impairments in Parkinson’s disease: a double-blinded randomized control trial. Healthcare . 2020;8(2):p. 113.
    1. Nieuwboer A., Kwakkel G., Rochester L., et al. Cueing training in the home improves gait-related mobility in Parkinson’s disease: the RESCUE trial. Journal of Neurology, Neurosurgery & Psychiatry . 2007;78(2):134–140.
    1. Rocha P. A., Porfírio G. M., Ferraz H. B., Trevisani V. F. M. Effects of external cues on gait parameters of Parkinson’s disease patients: a systematic review. Clinical Neurology and Neurosurgery . 2014;124:127–134.
    1. Suputtitada A., Chen C. P. C., Pongmala C., et al. The efficacy of a newly developed cueing device for gait mobility in Parkinson’s disease. Parkinson’s Disease . 2022;2022:7. doi: 10.1155/2022/7360414.7360414
    1. Ferster M., Mazilu S., Troester G. Gait parameters change prior to freezing in Parkinson’s disease: a data-driven study with wearable inertial units. EAI Endorsed Transactions on Ambient Systems . 2015;3 doi: 10.4108/eai.28-9-2015.2261411.
    1. Hausdorff J. M., Schaafsma J. D., Balash Y., Bartels A. L., Gurevich T., Giladi N. Impaired regulation of stride variability in Parkinson’s disease subjects with freezing of gait. Experimental Brain Research . 2003;149(2):187–194.
    1. Snijders A. H., Haaxma C. A., Hagen Y. J., Munneke M., Bloem B. R. Freezer or non-freezer: clinical assessment of freezing of gait. Parkinsonism & Related Disorders . 2012;18(2):149–154.
    1. Tan X. S., Pierres F., Dallman-Porter A., Hardie-Brown W., Kwon K. Y. Focused vibrotactile stimulation with cueing effect on freezing of gait in Parkinson’s disease: two case reports. Journal of movement disorders . 2021;14(3):236–238.
    1. Ziegler K., Schroeteler F., Ceballos-Baumann A. O., Fietzek U. M. A new rating instrument to assess festination and freezing gait in Parkinsonian patients. Movement Disorders . 2010;25(8):1012–1018.
    1. Fietzek U. M., Schulz S. J., Ziegler K., Ceballos-Baumann A. O. The minimal clinically relevant change of the FOG score. Journal of Parkinson’s Disease . 2020;10(1):325–332.
    1. Lang J. T., Kassan T. O., Devaney L. L., Colon-Semenza C., Joseph M. F. Test-Retest reliability and minimal detectable change for the 10-meter walk test in older adults with Parkinson’s disease. Journal of Geriatric Physical Therapy . 2016;39(4):165–170.
    1. Lindholm B., Nilsson M. H., Hansson O., Hagell P. The clinical significance of 10-m walk test standardizations in Parkinson’s disease. Journal of Neurology . 2018;265(8):1829–1835.
    1. Steffen T., Seney M. Test-retest reliability and minimal detectable change on balance and ambulation tests, the 36-itemshort-form health survey, and the unified Parkinson disease rating scale in people with parkinsonism. Physical Therapy . 2008;88(6):733–746.
    1. Perera S., Mody S. H., Woodman R. C., Studenski S. A. Meaningful change and responsiveness in common physical performance measures in older adults. Journal of the American Geriatrics Society . 2006;54(5):743–749.
    1. Bohannon R. W. Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants. Age and Ageing . 1997;26(1):15–19.
    1. Perrot S., Lantéri-Minet M. Patients’ Global Impression of Change in the management of peripheral neuropathic pain: clinical relevance and correlations in daily practice. European Journal of Pain . 2019;23(6):1117–1128.
    1. Byrom B., Breedon P., Tulkki-Wilke R., Platko J. V. Meaningful change: defining the interpretability of changes in endpoints derived from interactive and mHealth technologies in healthcare and clinical research. Journal of Rehabilitation and Assistive Technologies Engineering . 2020;7 doi: 10.1177/2055668319892778.205566831989277
    1. Dworkin R. H., Turk D. C., Wyrwich K. W., et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. The Journal of Pain . 2008;9(2):105–121.
    1. Toots A., Littbrand H., Holmberg H., et al. Walking aids moderate exercise effects on gait speed in people with dementia: a randomized controlled trial. Journal of the American Medical Directors Association . 2017;18(3):227–233.
    1. Barthel C., Mallia E., Debû B., Bloem B. R., Ferraye M. U. The practicalities of assessing freezing of gait. Journal of Parkinson’s Disease . 2016;6(4):667–674.
    1. Giladi N. Medical treatment of freezing of gait. Movement Disorders . 2008;23(S2):S482–S488.
    1. Bryant M. S., Rintala D. H., Hou J. G., et al. Gait variability in Parkinson’s disease: influence of walking speed and dopaminergic treatment. Neurological Research . 2011;33(9):959–964.
    1. Goldenberg M. M. Medical management of Parkinson’s disease. P and T: A Peer-Reviewed Journal for Formulary Management . 2008;33(10):590–606.
    1. Munnangi S., Sundjaja J. H., Singh K., Dua A., Angus L. D. StatPearls . Tampa, Florida, USA: StatPearls Publishing; 2022. Placebo effect.
    1. Dodd S., Dean O. M., Vian J., Berk M. A review of the theoretical and biological understanding of the nocebo and placebo phenomena. Clinical Therapeutics . 2017;39(3):469–476.
    1. O’Day J., Syrkin-Nikolau J., Anidi C., Kidzinski L., Delp S., Bronte-Stewart H. The turning and barrier course reveals gait parameters for detecting freezing of gait and measuring the efficacy of deep brain stimulation. PLoS One . 2020;15(4)e0231984
    1. Üğüt B. O., Kalkan A. C., Kahraman T., Dönmez Çolakoğlu B., Çakmur R., Genç A. Determinants of 6-minute walk test in people with Parkinson’s disease. Irish Journal of Medical Science . 2022

Source: PubMed

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