Gait Analysis in Neurological Disease



Status:Recruiting
Conditions:Other Indications, Parkinsons Disease, Neurology, Neurology, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 85
Updated:12/14/2018
Start Date:March 1, 2016
End Date:October 2019
Contact:Veronique Vanderhorst, MD
Email:vvanderh@bidmc.harvard.edu
Phone:617-667-0519

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Gait Pattern Analysis in Neurological Disease

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.

This study aims to determine whether the gait patterns in these subjects differ in
predictable and quantifiable ways from those of age- and sex-matched healthy controls. 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 syndromes. 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) and age-
and sex matched controls (n=40) will be recruited. 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.

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).
We found this trial at
1
site
Boston, Massachusetts 02215
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from
Boston, MA
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