Gait Analysis in Neurological Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT02994719
• Date of registration: 21/12/2015
• Prospective Registration: Yes
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Gait Analysis in Neurological Disease
• Scientific title: Gait Pattern Analysis in Neurological Disease
• Date of first enrolment: March 1, 2016
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02994719
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Veronique Vanderhorst, MD PhD

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington Disease

Atypical Parkinson Disease

Gait, Frontal

Multiple System Atrophy

Parkinsonian Disorders

Parkinson's Disease

Progressive Supranuclear Palsy

Corticobasal Degeneration

Intervention(s)

Drug: Anti-Parkinson medication

Device: Deep Brain Stimulation

Primary Outcome(s)

Gait speed [Time Frame: through study completion, an average of 1 year]

Secondary Outcome(s)

Stance duration [Time Frame: through study completion, an average of 1 year]

Swing duration [Time Frame: through study completion, an average of 1 year]

Cadence [Time Frame: through study completion, an average of 1 year]

Stride length [Time Frame: through study completion, an average of 1 year]

Secondary ID(s)

2015P000310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors