Gait Analysis in Neurological Disease

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02994719

Collaborator

(none)

120

Enrollment

Location

87.6

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Parkinsonian Disorders Atypical Parkinson Disease Progressive Supranuclear Palsy Multiple System Atrophy Corticobasal Degeneration Gait, Frontal Huntington Disease	Drug: Anti-Parkinson medication Device: Deep Brain Stimulation

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Gait Pattern Analysis in Neurological Disease

Actual Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Jun 20, 2023

Anticipated Study Completion Date :

Jun 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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 Device: 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.
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.

Outcome Measures

Primary Outcome Measures

Gait speed [through study completion, an average of 1 year]
Method of assessment: physiological parameter

Secondary Outcome Measures

Swing duration [through study completion, an average of 1 year]
Method of assessment: physiological parameter
Stance duration [through study completion, an average of 1 year]
Method of assessment: physiological parameter
Cadence [through study completion, an average of 1 year]
Method of assessment: physiological parameter
Stride length [through study completion, an average of 1 year]
Method of assessment: physiological parameter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).