Gait Analysis in Neurological Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorBeth Israel Deaconess Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Anti-Parkinson medication

    Drug

    During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.

  • Deep Brain Stimulation

    Device

    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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Neurological Disease subjects2 interventions
Group B: Healthy control subjects0 interventions
Group C: Ataxia Subjects0 interventions
Group D: Huntington Disease Subjects0 interventions

Trial outcomes

Primary outcomes

1

Gait speed

Method of assessment: physiological parameter

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Swing duration

Method of assessment: physiological parameter

Time frame
through study completion, an average of 1 year
2

Stance duration

Method of assessment: physiological parameter

Time frame
through study completion, an average of 1 year
3

Cadence

Method of assessment: physiological parameter

Time frame
through study completion, an average of 1 year
4

Stride length

Method of assessment: physiological parameter

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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