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The purpose of this study is to investigate whether speed-dependent measures of gait (so called gait signatures) can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders.
This study aims to determine whether the gait patterns, modeled as gait signatures, in these subjects differ in predictable and quantifiable ways from those of age- and sex-matched healthy controls (cross sectional data). This will be conducted by asking 40 Parkinsonian disorder subjects and 40 age-matched healthy control subjects to walk 9 trials over an 18 ft walkway embedded with pressure sensors at baseline, self-selected slower and faster speeds. In addition, the protocol aims to investigate whether clusters of gait patterns can be identified within subgroups of individuals with parkinsonian disorders with varying co-morbidities or treatment conditions as well as patients with ataxia or huntington's disease. For this aim an additional 20 Parkinsonian disorder subjects need to be recruited. Patients with parkinsonism as defined by UK PD Brain Bank Criteria (n=60), subjects with acquired or inherited ataxic syndromes (n=10), age- and sex matched controls (n=40) and young healthy controls (n=30) will be recruited. The cohort of young healthy controls serves to validate gait analysis modeling.There is an optional second visit in the protocol during which approximately 20 subjects with Parkinsonian disorders, who are willing to come off antiparkinson medication and if applicable, off both medication and deep brain stimulation, are asked to walk an additional 9 trials. The PD and older healthy control subjects have to option to be followed longitudinally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Healthy control subjects | The healthy control subjects will be age- and sex-matched to the Neurological Disease subjects. An additional young healthy control cohort will be used to validate gait analysis methodology. | ||
| Ataxia Subjects | The ataxia subjects will participate in an additional cohort that will test and validate the gait model. | ||
| Huntington Disease Subjects | The Huntington Disease subjects will participate in an additional cohort that will test and validate the gait model. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Parkinson medication | Drug | During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed | Method of assessment: physiological parameter | through study completion, an average of 1 year, with option of PD and older healthy controls to be followed longitudinally for the course of the disease |
| Measure | Description | Time Frame |
|---|---|---|
| Swing duration | Method of assessment: physiological parameter | through study completion, an average of 1 year |
| Stance duration | Method of assessment: physiological parameter |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with Parkinsonism as defined by UK PD Brain Bank Criteria. The study population includes subjects with Parkinson's Disease and may also 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. Subgroups include subjects with ataxia and huntington's disease and control subjects without known neurological disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center BIDMC | Boston | Massachusetts | 02215 | United States |
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|
| Deep Brain Stimulation | Device | 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. |
|
| through study completion, an average of 1 year |
| Cadence | Method of assessment: physiological parameter | through study completion, an average of 1 year |
| Stride length | Method of assessment: physiological parameter | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| C566823 | Parkinson Disease, Familial, Type 1 |
| D013494 | Supranuclear Palsy, Progressive |
| D019578 | Multiple System Atrophy |
| D000088282 | Corticobasal Degeneration |
| D020233 | Gait Disorders, Neurologic |
| D006816 | Huntington Disease |
| D020754 | Spinocerebellar Ataxias |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002524 | Cerebellar Ataxia |
| D002526 | Cerebellar Diseases |
| D013132 | Spinocerebellar Degenerations |
| D013118 | Spinal Cord Diseases |
| D001259 | Ataxia |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
| D000077487 | Pramipexole |
| C046649 | ropinirole |
| D000547 | Amantadine |
| D000077867 | Tolcapone |
| C071192 | entacapone |
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D009596 | Nitrophenols |
| D010636 | Phenols |
| D007659 | Ketones |
| D009574 | Nitro Compounds |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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