ACCEPTABILITY OF A STUDY DESIGN USING A NEW CUEING DEVICE IN PEOPLE WITH PARKINSON’S DISEASE EXPERIENCING FREEZING OF GAIT

A. Wilhelm¹, T. Riedl¹, C. Paumann¹, J. Janssen¹

¹IMC University of Applied Science Krems, Health Sciences, Krems an der Donau, Austria

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 Vibrotactile Stimulation Device (SVSD) with cueing function has been developed, however the clinical effects of this device are yet to be fully investigated.

Purpose: 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 clinical randomized cross-over study. People with PD were recruited from self-support groups to take 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 the 10 Metre Walk Test (10MWT), the Freezing of Gait Score (FoG-Score) and Patient Global Impression of Change Scale (PGI-C Scale) with and without the SVSD. Gait parameters (double step length, cadence and symmetry) were captured during the 10MWT with gait analysis sensor insoles. Quantitative data was analysed descriptively, qualitative data was analysed using the inductive approach from Mayring.

Results: Four women and nine men, with a median age 66 years and a Hoehn and Yahr score ranging from 1 to 4, participated in the study. The median score of all aspects of the study design was very satisfactory (IQR very satisfactory- satisfactory). However, feedback from open ended questions provided additional ideas and considerations for adaptations of future clinical studies. These encompassed: more detailed information about the mechanism of the SVSD, the time of medication intake prior to data collection, and the ability to change the vibration intensity and frequency of the SVSD. No participant experienced FoG during the 10MWT and 8/13 participants froze during the FoG score. All participants could perform the secondary outcome measures and were deemed feasible, however gait parameters for one 10MWT could not be recorded.

Conclusions: The proposed study design was acceptable for people with PD. The generalisability of the study is questioned due to the limited number of participants and the fact that the participants were faster in the 10MWT than people with PD from normative data. In line with literature the participants predominantly experienced FoG while performing dual tasks.

Implications: Currently, there is limited evidence on the effectivity of this SVSD on FoG. This study design, with small adaptations, could be used for larger clinical studies to evaluate a possible effect on FoG in people with PD.

Funding acknowledgements: This study was funded with a grant by the province of Lower Austria – NÖGUS (Lower Austrian Health and Social Fund).

Keywords:
Freezing of Gait
Idiopathic Parkinson’s Disease
Feasibility

Topics:
Neurology: Parkinson's disease

Did this work require ethics approval? Yes

Institution: Office of the Federal Government of Lower Austria

Committee: Ethics Committee of Lower Austria

Ethics number: GS4-EK-4/742-2021