Acceptability of a study design in people with Parkinson’s disease - a feasibility study

Parkinson’s disease (PD) is the second most common neurodegenerative disease in the elderly population (Gao, 2020). Freezing of Gait (FoG) is a disabling symptom of PD and is defined as a “brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk” (Giladi, 2008). Compensation strategies such as cueing can reduce FoG severity and improve gait parameters (Ginis, 2018). FoG reduces the patient’s mobility and their independence and has a significantly impact to their quality of life (Walton, 2015). Cues are targets or references that support the execution of a movement (Nieuwboer, 2007). The cueing device that was used in this study, was a wearable non-invasive sternal vibrotactile stimulation device (SVSD). The sensor sole used in this study was a wireless, instrumented (pressure and IMU sensors) insole which recorded the symmetry of the gait pattern and important gait parameters such as step length, cadence or step duration. The aim of this study was to investigate, if a randomised cross-over study design using a SVSD and the sensor insoles together, while performing the FoG-Score and the 10m walk test, was acceptable for participants. The objective was to gather information and the participants feedback to use in further and larger studies. With the results of this study, it was shown that this study design is feasible for people with PD. The data from this study can be used to calculate the sample size to conduct a randomized clinical trial.