Gait Analysis in Neurological Disease

NCT02994719 | Recruiting

• 1 other identifier: 2015P000310
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Parkinsonian Disorders; Atypical Parkinson Disease; Progressive Supranuclear Palsy; Multiple System Atrophy; Corticobasal Degeneration; Gait, Frontal; Huntington Disease

Outcome Measures

Primary Outcomes (1)

• Gait speed

  Method of assessment: physiological parameter

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Swing duration

  through study completion, an average of 1 year

• Stance duration

  through study completion, an average of 1 year

• Cadence

  through study completion, an average of 1 year

• Stride length

  through study completion, an average of 1 year

Study Arms (4)

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.

Drug: Anti-Parkinson medication; Device: Deep Brain Stimulation

Healthy control subjects

The healthy control subjects will be age- and sex-matched to the Neurological Disease subjects.

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.

Interventions

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.

Also known as: Carbidopa/levodopa, pramipexole, ropinirole, amantadine, tolcapone, entacapone

Neurological Disease subjects

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.

Neurological Disease subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Clinical Research Center BIDMC

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Parkinson Disease, Familial, Type 1; Supranuclear Palsy, Progressive; Multiple System Atrophy; Corticobasal Degeneration; Gait Disorders, Neurologic; Huntington Disease

Interventions

carbidopa, levodopa drug combination; Pramipexole; ropinirole; Amantadine; Tolcapone; entacapone; Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Nitrophenols; Phenols; Ketones; Nitro Compounds; Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Veronique Vanderhorst, MD PhD

CONTACT

617-667-0519; vvanderh@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 16, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)