Parkinson's Disease (PD)NCT06975059
Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients
A study testing NUSHU shoe in people with Parkinson's Disease (PD), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- NUSHU shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to Jul 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Has willingness and ability to comply with study requirements
- Male or female ≥ 18 years of age.
- No neurological disease or other significant gait impairment as deemed by the study investigator
Who cannot join
- 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
- Inability to wear interventional device
- Unable to ambulate independently at least with assistive walking device but without additional person assistance
Show all 10Show fewer
- Pregnant or planning pregnancy within study timeframe
- Montreal Cognitive Assessment (MoCA) score < 22 at screening
- Resides in a nursing home or assisted care facility
- Healthy Controls:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls
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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- NUSHU shoe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUSHU shoeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NUSHU shoe |
| 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. Receives: Device: NUSHU shoe |
| 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. Receives: Device: NUSHU shoe |
| 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. Receives: Device: NUSHU shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, 18 weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline and In 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 May 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2030 (estimated)
Why it stopped: Enrollment goals of subjects with Parkinson's disease have been met, and the study has had difficulty enrolling control, non-PD subjects. The study has suspended recruitment while the research team evaluates the best plan going forward.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harini Sarva, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975059
- Sponsor's protocol ID
- 24-05027451
- Status last verified
- Aug 2026
- First submitted
- 8 May 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT06975059
- Acronym / sponsor ID
- 24-05027451
- Conditions
- Parkinson's Disease (PD)
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment goals of subjects with Parkinson's disease have been met, and the study has had difficulty enrolling control, non-PD subjects. The study has suspended recruitment while the research team evaluates the best plan going forward.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (Early) | Experimental | Device: NUSHU shoeThe 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. |
| Parkinson's Disease (Moderate) | Experimental | Device: NUSHU shoeThe 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. |
| Parkinson's Disease (Advanced) | Experimental | Device: NUSHU shoeThe 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. |
| Healthy Controls | Active comparator | Device: NUSHU shoeHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Has willingness and ability to comply with study requirements
Key exclusion criteria (10 listed)
- 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
- Inability to wear interventional device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUSHU shoeThe 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. | Device | Healthy Controls, Parkinson's Disease (Advanced), Parkinson's Disease (Early), Parkinson's Disease (Moderate) |
Primary outcome
Mean Score of Comfort Level of Device in Satisfaction Survey
Time frame: At Safety Follow Up (Week 18)
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
Time frame: At Safety Follow Up (Week 18)
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
Time frame: Through study completion, 18 weeks
We would like to measure the retention rate to assess feasibility. The lowest ratio would be 0, and the highest ratio would be 1.
11 secondary outcomes
Mean Change from Baseline to Week 12 in TUG test
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in FOG Questionnaire
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in MDS-UPDRS III
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Stride Time
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Stride Length
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Swing Time
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Stance Time
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Velocity
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Cadence
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Swing Phase
Time frame: At Baseline and In 12 Weeks
Mean Change from Baseline to Week 12 in Stance Phase
Time frame: At Baseline and In 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harini Sarva, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUSHU shoe in people with Parkinson's Disease (PD), run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of Comfort Level of Device in Satisfaction Survey (time frame: At Safety Follow Up (Week 18)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.