Gait Analysis in Neurological Disease

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Brief Title

Gait Analysis in Neurological Disease

Official Title

Gait Pattern Analysis in Neurological Disease

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.
    


Study Type

Observational


Primary Outcome

Gait speed

Secondary Outcome

 Swing duration

Condition

Parkinson's Disease

Intervention

Anti-Parkinson medication

Study Arms / Comparison Groups

 Neurological Disease subjects
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

March 1, 2016

Completion Date

June 20, 2023

Primary Completion Date

June 20, 2023

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).
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02994719

Organization ID

2015P000310


Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center


Study Sponsor

, , 


Verification Date

July 2021