Gait Analysis in Neurological Disease
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|ClinicalTrials.gov Identifier: NCT02994719|
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment|
|Parkinson's Disease Parkinsonian Disorders Atypical Parkinson Disease Progressive Supranuclear Palsy Multiple System Atrophy Corticobasal Degeneration Gait, Frontal||Drug: Anti-Parkinson medication Device: Deep Brain Stimulation|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||Gait Pattern Analysis in Neurological Disease|
|Actual Study Start Date :||March 1, 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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.
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.
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.
The ataxia subjects will participate in an additional cohort that will test and validate the gait model.
- 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
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
|Contact: Veronique Vanderhorst, MDemail@example.com|
|Contact: Laura D Hernandez, BAfirstname.lastname@example.org|
|United States, Massachusetts|
|Clinical Research Center BIDMC||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Ludy Shih, MD||Beth Israel Deaconess Medical Center|