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Gait Analysis in Neurological Disease

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ClinicalTrials.gov Identifier: NCT02994719
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Veronique Vanderhorst, Beth Israel Deaconess Medical Center

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

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Gait Pattern Analysis in Neurological Disease
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Group/Cohort 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.



Primary Outcome Measures :
  1. Gait speed [ Time Frame: through study completion, an average of 1 year ]
    Method of assessment: physiological parameter


Secondary Outcome Measures :
  1. Swing duration [ Time Frame: through study completion, an average of 1 year ]
    Method of assessment: physiological parameter

  2. Stance duration [ Time Frame: through study completion, an average of 1 year ]
    Method of assessment: physiological parameter

  3. Cadence [ Time Frame: through study completion, an average of 1 year ]
    Method of assessment: physiological parameter

  4. Stride length [ Time Frame: through study completion, an average of 1 year ]
    Method of assessment: physiological parameter



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994719


Contacts
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Contact: Veronique Vanderhorst, MD 617-667-0519 vvanderh@bidmc.harvard.edu
Contact: Laura D Hernandez, BA 617-667-4746 ldhernan@bidmc.harvard.edu

Locations
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United States, Massachusetts
Clinical Research Center BIDMC Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Ludy Shih, MD Beth Israel Deaconess Medical Center

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Responsible Party: Veronique Vanderhorst, Assistant Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02994719     History of Changes
Other Study ID Numbers: 2015P000310
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Parkinson Disease
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Gait Disorders, Neurologic
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Amantadine
Carbidopa
Pramipexole
Ropinirole
Entacapone