About this trial
The purpose of this study is to investigate whether speed-dependent measures of gait can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial population
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.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Anti-Parkinson medication
DrugDuring the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.
Deep Brain Stimulation
DeviceDuring 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.
Treatment groups
Trial outcomes
Primary outcomes
Gait speed
Method of assessment: physiological parameter
Secondary outcomes
Swing duration
Method of assessment: physiological parameter
Stance duration
Method of assessment: physiological parameter
Cadence
Method of assessment: physiological parameter
Stride length
Method of assessment: physiological parameter
Sponsors and contacts
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