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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease (Early) | Experimental | The early PD group will be those within 3 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic. |
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| Parkinson's Disease (Moderate) | Experimental | The moderate PD group will be those with 4-7 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic. |
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| Parkinson's Disease (Advanced) | Experimental | The advanced PD group will be those with at least 8 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic. |
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| Healthy Controls | Active Comparator | Healthy controls will include those without any neurological disease or other significant gait impairment. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUSHU shoe | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Safety Follow Up (Week 18) |
| 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. | At Safety Follow Up (Week 18) |
| 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. | Through study completion, 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Parkinson's Disease:
Inclusion Criteria:
Exclusion Criteria:
Healthy Controls:
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harini Sarva, MD | Contact | 212-746-1685 | has9059@med.cornell.edu | |
| Clinical Research Coordinator | Contact | kyn4002@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Harini Sarva, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell | Recruiting | New York | New York | 10021 | United States |
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| At Baseline and In 12 Weeks |
| 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. | At Baseline and In 12 Weeks |
| 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. | At Baseline and In 12 Weeks |
| 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. | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Stride Length | The NUSHU shoe measures the stride length: the distance covered between the same spot where one foot hits the ground and the next time the same foot hits the ground again. This distance is collected in meters. | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Swing Time | The NUSHU shoes measure the swing time: the amount of time the foot spends off the ground in the gait cycle, defined by the time from toe off to heel strike of the same foot. The time is collected in seconds. | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Stance Time | The NUSHU shoes measure the stance time: the duration of the time between heel strike and toe off of the same foot. This time is collected in seconds. | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Velocity | The NUSHU shoes measure the velocity: mean in-plane velocity of each gait cycle (m/s). | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Cadence | The NUSHU shoes measure the cadence: number of strides per minute. | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Swing Phase | The NUSHU Shoes measure the swing phase: ratio of swing time with respect to gait cycle duration. | At Baseline and In 12 Weeks |
| Mean Change from Baseline to Week 12 in Stance Phase | The NUSHU shoes measure the stance phase: ratio of stance time with respect to gait cycle duration. | At Baseline and In 12 Weeks |