Gait Pattern Analysis in Neurological Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
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• 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).

Locations
United States
Massachusetts
Clinical Research Center BIDMC
RECRUITING
Boston
Contact Information
Primary
Veronique Vanderhorst, MD PhD
vvanderh@bidmc.harvard.edu
617-667-0519
Time Frame
Start Date: 2016-03-01
Estimated Completion Date: 2026-06-20
Participants
Target number of participants: 120
Treatments
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.
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.
Authors
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov