Gait Analysis in Neurological Disease

Parkinson's Disease Clinical Trial

Official title:

Gait Pattern Analysis in Neurological Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02994719
• Other study ID #: 2015P000310
• Status: Recruiting
• Start date: March 1, 2016
• Est. completion date: June 20, 2025

Study information

• Verified date: April 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Veronique Vanderhorst, MD PhD
• Phone: 617-667-0519
• Email: vvanderh[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 20, 2025
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atypical Parkinson Disease
• Corticobasal Degeneration
• Gait Disorders, Neurologic
• Gait, Frontal
• Huntington Disease
• Multiple System Atrophy
• Nervous System Diseases
• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders
• Progressive Supranuclear Palsy
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Clinical Research Center BIDMC	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	Method of assessment: physiological parameter	through study completion, an average of 1 year
Secondary	Swing duration	Method of assessment: physiological parameter	through study completion, an average of 1 year
Secondary	Stance duration	Method of assessment: physiological parameter	through study completion, an average of 1 year
Secondary	Cadence	Method of assessment: physiological parameter	through study completion, an average of 1 year
Secondary	Stride length	Method of assessment: physiological parameter	through study completion, an average of 1 year