Gait Analysis in Neurological Disease
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ClinicalTrials.gov Identifier: NCT02994719 |
Recruitment Status :
Active, not recruiting
First Posted : December 16, 2016
Last Update Posted : July 26, 2021
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Condition or disease | Intervention/treatment |
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Parkinson's Disease Parkinsonian Disorders Atypical Parkinson Disease Progressive Supranuclear Palsy Multiple System Atrophy Corticobasal Degeneration Gait, Frontal Huntington Disease | Drug: Anti-Parkinson medication Device: Deep Brain Stimulation |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Gait Pattern Analysis in Neurological Disease |
Actual Study Start Date : | March 1, 2016 |
Estimated Primary Completion Date : | June 20, 2023 |
Estimated Study Completion Date : | June 20, 2023 |

Group/Cohort | Intervention/treatment |
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Neurological Disease subjects
Parkinson's Disease and other Parkinsonian Disorders subjects. Other Parkinsonian Disorders include Atypical Parkinsonism such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Primary Gait Freezing Disorder, Indeterminate Parkinsonian Syndrome. During the first visit no intervention will take place. There is an optional second visit during which subjects with Parkinson's Disease are asked to come come off antiparkinson medication and if applicable, off both medication and deep brain stimulation.
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Drug: Anti-Parkinson medication
During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.
Other Names:
Device: Deep Brain Stimulation During the optional second visit subjects with neurological disease already treated with deep brain stimulation are asked to come temporarily stop deep brain stimulation and resume stimulation, with walking trials done in each condition. |
Healthy control subjects
The healthy control subjects will be age- and sex-matched to the Neurological Disease subjects.
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Ataxia Subjects
The ataxia subjects will participate in an additional cohort that will test and validate the gait model.
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Huntington Disease Subjects
The Huntington Disease subjects will participate in an additional cohort that will test and validate the gait model.
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- Gait speed [ Time Frame: through study completion, an average of 1 year ]Method of assessment: physiological parameter
- Swing duration [ Time Frame: through study completion, an average of 1 year ]Method of assessment: physiological parameter
- Stance duration [ Time Frame: through study completion, an average of 1 year ]Method of assessment: physiological parameter
- Cadence [ Time Frame: through study completion, an average of 1 year ]Method of assessment: physiological parameter
- Stride length [ Time Frame: through study completion, an average of 1 year ]Method of assessment: physiological parameter

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 18-85 (for both healthy and affected subjects).
- Presence of at least 2 of the following: bradykinesia, rest tremor, rigidity, postural instability (UK PD Brain Bank Criteria) (Affected subjects only).
- Montreal Cognitive Assessment will be employed to determine whether subjects will need the assent of a legally authorized representative. Subjects with MOCA ≤ 21 will be consented only with the assent of the subject and informed consent of the authorized legal representative (Affected subjects only).
- These may include subjects who may have indeterminate parkinsonism, when it is not clear whether they have idiopathic Parkinson's Disease versus one of the Atypical Parkinsonisms, such as Vascular Parkinsonism, Multiple System Atrophy, Progressive Supranuclear Palsy, Normal Pressure Hydrocephalus or Corticobasal Degeneration (Affected subjects only).
- Subjects with assistive devices will be eligible for the study and may use them during the study (Affected subjects only).
- Absence of complaints regarding difficulty walking such as arthritic pain, fatigue during walking or slowness of walking (Healthy subjects only).
Exclusion Criteria:
- Presence of alternative explanation for parkinsonism such as head trauma, drug-induced parkinsonism (affected subjects only).
- Currently being treated for major medical illness requiring recent hospitalization (<14 days) (for both healthy and affected subjects).
- Currently participating in another clinical study with an intervention arm (for both healthy and affected subjects).
- Inability to consent due to cognitive impairment and absence of legally authorized representative (for both healthy and affected subjects).
- Subjects with any cardiac, pulmonary conditions (congestive heart failure requiring hospitalization within the past 90 days, recent myocardial infarction < 90 days, supplemental oxygen-requiring subjects due to cardiac or pulmonary conditions) that limit their ability to safely participate in a walking trial (for both healthy and affected subjects).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994719
United States, Massachusetts | |
Clinical Research Center BIDMC | |
Boston, Massachusetts, United States, 02215 |
Responsible Party: | Veronique Vanderhorst, Associate Professor of Neurology, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT02994719 |
Other Study ID Numbers: |
2015P000310 |
First Posted: | December 16, 2016 Key Record Dates |
Last Update Posted: | July 26, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Supranuclear Palsy, Progressive Brain Diseases Paralysis Parkinson Disease Huntington Disease Multiple System Atrophy Shy-Drager Syndrome Nervous System Diseases Parkinsonian Disorders Gait Disorders, Neurologic Basal Ganglia Diseases Central Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |
Dementia Chorea Dyskinesias Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders Primary Dysautonomias Autonomic Nervous System Diseases Hypotension Vascular Diseases Cardiovascular Diseases Ophthalmoplegia Ocular Motility Disorders |