Clinical Research Center BIDMC
Boston, Massachusetts, 02215, United States
NCT Number: NCT02994719
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 is active but is not currently recruiting participants.
18 year–85 year
All sexes
Observational
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Carbidopa/levodopa, pramipexole, ropinirole, amantadine, tolcapone, entacapone
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.
Time frame: 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
Method of assessment: physiological parameter
Time frame: through study completion, an average of 1 year
Method of assessment: physiological parameter
Time frame: through study completion, an average of 1 year
Method of assessment: physiological parameter
Time frame: through study completion, an average of 1 year
Method of assessment: physiological parameter
Time frame: through study completion, an average of 1 year
Method of assessment: physiological parameter
Beth Israel Deaconess Medical Center
Other
Gait Pattern Analysis in Neurological Disease
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