Parkinson's DiseaseNCT02994719
Gait Analysis in Neurological Disease
An observational study of Parkinson's Disease and Parkinsonian Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether speed-dependent measures of gait (so called gait signatures) can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Parkinsonian Disorders, Atypical Parkinson Disease
- What is being tested?
- Anti-Parkinson medication and Deep Brain Stimulation
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 7 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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. Subgroups include subjects with ataxia and huntington's disease and control subjects without known neurological disease.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center BIDMC
Boston, Massachusetts, 02215
About this study
Official title: Gait Pattern Analysis in Neurological Disease
The purpose of this study is to investigate whether speed-dependent measures of gait (so called gait signatures) can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders.
Read the detailed description
This study aims to determine whether the gait patterns, modeled as gait signatures, in these subjects differ in predictable and quantifiable ways from those of age- and sex-matched healthy controls (cross sectional data). 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 or huntington's disease. 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), age- and sex matched controls (n=40) and young healthy controls (n=30) will be recruited. The cohort of young healthy controls serves to validate gait analysis modeling.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. The PD and older healthy control subjects have to option to be followed longitudinally.
- Conditions
- Parkinson's Disease, Parkinsonian Disorders, Atypical Parkinson Disease, Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration
- Being tested
- Anti-Parkinson medication, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Parkinson Disease, Familial, Type 1, Supranuclear Palsy, Progressive, Multiple System Atrophy, Corticobasal Degeneration, Gait Disorders, Neurologic, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Parkinson medicationDrug
Also called Carbidopa/levodopa, pramipexole, ropinirole, amantadine
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anti-Parkinson medication; Device: Deep Brain Stimulation | |
| Healthy control subjects | The healthy control subjects will be age- and sex-matched to the Neurological Disease subjects. An additional young healthy control cohort will be used to validate gait analysis methodology. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Method of assessment: physiological parameter
Measured: through study completion, an average of 1 year, with option of PD and older healthy controls to be followed longitudinally for the course of the disease
Secondary outcomes (4)
Swing duration
Method of assessment: physiological parameter
Measured: through study completion, an average of 1 year
Stance duration
Method of assessment: physiological parameter
Measured: through study completion, an average of 1 year
Cadence
Method of assessment: physiological parameter
Measured: through study completion, an average of 1 year
Stride length
Method of assessment: physiological parameter
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start1 Mar 2016
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Vanderhorst, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994719
- Sponsor's protocol ID
- 2015P000310
- Status last verified
- Jul 2026
- First submitted
- 21 Dec 2015
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Pattern Analysis in Neurological Disease
- ClinicalTrials.gov ID
- NCT02994719
- Acronym / sponsor ID
- 2015P000310
- Conditions
- Parkinson's Disease, Parkinsonian Disorders, Atypical Parkinson Disease, Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether speed-dependent measures of gait (so called gait signatures) 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, modeled as gait signatures, in these subjects differ in predictable and quantifiable ways from those of age- and sex-matched healthy controls (cross sectional data). 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 or huntington's disease. 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), age- and sex matched controls (n=40) and young healthy controls (n=30) will be recruited. The cohort of young healthy controls serves to validate gait analysis modeling.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. The PD and older healthy control subjects have to option to be followed longitudinally.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neurological Disease subjects | – | Drug: Anti-Parkinson medication, Device: Deep Brain StimulationParkinson'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. An additional young healthy control cohort will be used to validate gait analysis methodology. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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. Subgroups include subjects with ataxia and huntington's disease and control subjects without known neurological disease.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Parkinson medicationAlso: Carbidopa/levodopa, pramipexole, ropinirole, amantadineDuring the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication. | Drug | Neurological Disease subjects |
| Deep Brain StimulationDuring 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. | Device | Neurological Disease subjects |
Primary outcome
Gait speed
Time frame: through study completion, an average of 1 year, with option of PD and older healthy controls to be followed longitudinally for the course of the disease
Method of assessment: physiological parameter
4 secondary outcomes
Swing duration
Time frame: through study completion, an average of 1 year
Stance duration
Time frame: through study completion, an average of 1 year
Cadence
Time frame: through study completion, an average of 1 year
Stride length
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinsonian Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: through study completion, an average of 1 year, with option of PD and older healthy controls to be followed longitudinally for the course of the disease). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.