Gait Analysis in Neurological Disease

NCT ID: NCT02994719

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2026-06-20

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.

Detailed Description

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Anti-Parkinson medication

Intervention Type: 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.

Deep Brain Stimulation

Intervention Type: 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.

Healthy control subjects

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

No interventions assigned to this group

Ataxia Subjects

The ataxia subjects will participate in an additional cohort that will test and validate the gait model.

No interventions assigned to this group

Huntington Disease Subjects

The Huntington Disease subjects will participate in an additional cohort that will test and validate the gait model.

No interventions assigned to this group

Interventions

Anti-Parkinson medication

During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.

Intervention Type: DRUG

Deep Brain Stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

Carbidopa/levodopa; pramipexole; ropinirole; amantadine; tolcapone; entacapone

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Veronique Vanderhorst

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Research Center BIDMC

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Veronique Vanderhorst, MD PhD

Role: CONTACT

vvanderh@bidmc.harvard.edu

617-667-0519

Other Identifiers

2015P000310

Identifier Type: -

Identifier Source: org_study_id