Gait changes in Parkinson's disease are complex, variable, and difficult to detect during short clinic assessments. The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally provides vibrational feedback that can potentially help gait difficulties experienced by Parkinson's patients.
Male or female ≥ 18 years of age.
A diagnosis of Parkinson's disease
Able to give written informed consent (as determined by the investigator)
Can converse in English and read and perform all study activities
Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD
A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy
Persons with disorders other than PD significantly affecting gait as determined by the investigator
History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator
Parallel
NUSHU shoe
DeviceThe NUSHU shoe, created by Magnes AG, can measure real-time detection of gait analysis while providing vibrotactile stimulus to the study participant through machine learning sensors. This may provide a feedback mechanism that acts as therapy for gait difficulties.
Mean Score of Comfort Level of Device in Satisfaction Survey
The satisfaction survey contains 2 demographic questions and 5 questions about participant satisfaction completed at end of study participation. The comfort level of the device question is the following: How would you rate the comfort level of the device? The scale is 0, 1, 2, 3, 4, 5, with 0 meaning most uncomfortable and 5 meaning most comfortable. Mean score for each individual question will be provided.
Mean Score of Ease of Using Device in Satisfaction Survey
The satisfaction survey contains 2 demographic questions and 5 questions about participant satisfaction completed at end of study participation. The comfort level of the device question is the following: How easy was it to use the device? The scale is 0, 1, 2, 3, 4, 5, with 0 meaning very easy and 5 meaning very difficult. Mean score for each individual question will be provided.
Ratio of Participants Who Completed Study to Total Number of Participants Enrolled
We would like to measure the retention rate to assess feasibility. The lowest ratio would be 0, and the highest ratio would be 1.
Mean Change from Baseline to Week 12 in TUG test
Timed Up and Go test assesses mobility, balance, walking ability, and fall risk in older adults by measuring how quickly the patient can stand up, walk 10 feet, turn around, walk back, and sit down. The score is the amount of time taken in seconds. There is no highest nor lowest score. The higher the time, the more problems the patient has with gait and requires gait aid.
Mean Change from Baseline to Week 12 in FOG Questionnaire
Freezing of Gait questionnaire assesses FOG severity unrelated to falls, FOG frequency, gait disturbances, and relationship to clinical features associated with gait and motor aspects in Parkinson's patients. The score ranges from 0 to 24, and high scores correspond to more severe FOG.
Mean Change from Baseline to Week 12 in MDS-UPDRS III
The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor examination; to be completed in the on-medication state) has instructions for the rater to give or demonstrate to the participant; it is completed by the investigator. Each question has a 0-4 rating scale. The total scores range from 0 to 132, with higher scores indicate increased severity.
Mean Change from Baseline to Week 12 in Stride Time
The NUSHU shoe measures the stride time: the time elapsed between the first contact of two consecutive footsteps of the same foot. This time is collected in seconds.
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