Motor ControlNCT04616508
Online Motor Control in People With Parkinson's Disease
A study of Motor Control and Parkinson Disease, run by University of Delaware at 1 site in United States.
Trial summary
This study aims to better understand how people with Parkinson's control reaching movements. Specifically, we are asking how these individuals respond to different environmental perturbations. Testing includes reaching movements made within a virtual reality set-up. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Control, Parkinson Disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 12 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age 18-85 years
- Able to perform reaching movements of ~20 cm (8 inches)
- MMSE score ≥ 26/30
- Willing and able to attend all testing sessions
- Diagnosis of idiopathic Parkinson's disease per self report
- Currently taking dopaminergic/dopamine agonist medication
Who cannot join
- Any chronic or recent upper extremity musculoskeletal conditions that affects reaching
- Any neurological disorders other than Parkinson's disease (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19713
Joie Tang
Hyosub Kim, PhD
About this study
This study aims to better understand how people with Parkinson's control reaching movements. Specifically, we are asking how these individuals respond to different environmental perturbations. Testing includes reaching movements made within a virtual reality set-up.
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting approximately up to 10 million people worldwide and with 60,000 new cases diagnosed annually in the U.S. alone. Some of the most common signs and symptoms in individuals with PD are slowed and small movements and difficulty in movement initiation. The ability to correct movements online in response to environmental changes is an important part of daily living. Online movement corrections in reaching refer to the ability to smoothly change how and where you reach in response to a change in the environment. For example, one can adjust the position of the hand and arm when trying to catch a butterfly flying in the air. Generally speaking, online movement corrections can happen in response to visual perturbations (e.g., trying to catch a butterfly) or to force perturbations (e.g., someone knocks your hand while you're holding a coffee mug). Since individuals with PD have trouble with movements, it stands to reason that they may have problems with online movement corrections. Surprisingly, very little is known about online movement corrections in individuals with PD. The current evidence suggests that individuals with PD can make online movement corrections to small visual perturbations, but whether they can successfully respond to large visual perturbations is debatable. Furthermore, whether individuals with PD can make online movement corrections to force perturbations has not been studied. The aim of this project is to investigate if individuals with PD can make online movement corrections during reaching to visual and/or force perturbations. We will test both individuals with PD and age-matched healthy controls. They will perform reaching movements while visual or force perturbations are applied. We will use various perturbation strengths in order to test for potential differences in responses to small and large perturbations. Results from this study will provide new information on how individuals with PD make online movement corrections, and possibly provide insight to improving rehabilitation for PD.
- Conditions
- Motor Control, Parkinson Disease
- Being tested
- motor control assessment
- Keywords
- motor control, Parkinson disease, motor learning
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor control assessmentBehavioural
Basic science study of control of reaching movements
| Study group | Role | What they receive |
|---|---|---|
| Behavioral testing | Experimental | Not described Receives: Behavioral: motor control assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-point errors
Euclidean distance from target to final hand position (units: cm); measurement derived from position data sampled at 1000 Hz
Measured: during intervention
Reaction times
Time from visual target presentation to movement onset (units: ms); measurement derived from position data sampled at 1000 Hz
Measured: during intervention
Movement times
Time from movement onset to movement end (units: ms); measurement derived from position data sampled at 1000 Hz
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start12 Dec 2018
- Primary completion12 Dec 2024 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ControlStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Hyosub Kim, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616508
- Sponsor's protocol ID
- 1358328-5
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Motor Control in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04616508
- Acronym / sponsor ID
- 1358328-5
- Conditions
- Motor Control, Parkinson Disease
- Keywords
- motor control, Parkinson disease, motor learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 5 Nov 2020 (actual)
- 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.
This study aims to better understand how people with Parkinson's control reaching movements. Specifically, we are asking how these individuals respond to different environmental perturbations. Testing includes reaching movements made within a virtual reality set-up.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting approximately up to 10 million people worldwide and with 60,000 new cases diagnosed annually in the U.S. alone. Some of the most common signs and symptoms in individuals with PD are slowed and small movements and difficulty in movement initiation. The ability to correct movements online in response to environmental changes is an important part of daily living. Online movement corrections in reaching refer to the ability to smoothly change how and where you reach in response to a change in the environment. For example, one can adjust the position of the hand and arm when trying to catch a butterfly flying in the air. Generally speaking, online movement corrections can happen in response to visual perturbations (e.g., trying to catch a butterfly) or to force perturbations (e.g., someone knocks your hand while you're holding a coffee mug). Since individuals with PD have trouble with movements, it stands to reason that they may have problems with online movement corrections. Surprisingly, very little is known about online movement corrections in individuals with PD. The current evidence suggests that individuals with PD can make online movement corrections to small visual perturbations, but whether they can successfully respond to large visual perturbations is debatable. Furthermore, whether individuals with PD can make online movement corrections to force perturbations has not been studied. The aim of this project is to investigate if individuals with PD can make online movement corrections during reaching to visual and/or force perturbations. We will test both individuals with PD and age-matched healthy controls. They will perform reaching movements while visual or force perturbations are applied. We will use various perturbation strengths in order to test for potential differences in responses to small and large perturbations. Results from this study will provide new information on how individuals with PD make online movement corrections, and possibly provide insight to improving rehabilitation for PD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral testing | Experimental | Behavioral: motor control assessment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-85 years
- Able to perform reaching movements of ~20 cm (8 inches)
- MMSE score ≥ 26/30
- Willing and able to attend all testing sessions
- Diagnosis of idiopathic Parkinson's disease per self report
Key exclusion criteria (2 listed)
- Any chronic or recent upper extremity musculoskeletal conditions that affects reaching
- Any neurological disorders other than Parkinson's disease (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
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 |
|---|---|---|
| motor control assessmentBasic science study of control of reaching movements | Behavioural | Behavioral testing |
Primary outcome
End-point errors
Time frame: during intervention
Euclidean distance from target to final hand position (units: cm); measurement derived from position data sampled at 1000 Hz
Reaction times
Time frame: during intervention
Time from visual target presentation to movement onset (units: ms); measurement derived from position data sampled at 1000 Hz
Movement times
Time frame: during intervention
Time from movement onset to movement end (units: ms); measurement derived from position data sampled at 1000 Hz
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 5 Nov 2020.
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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.
Hyosub Kim, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Motor Control and Parkinson Disease, run by University of Delaware 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 2 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: looking for participants now, as of the sponsor's last update on 5 Nov 2020. 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?
Contact Hyosub Kim, PhD (302-831-4263, hyosub@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-point errors (time frame: during intervention). The study lists 3 primary outcomes in all. 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 5 Nov 2020.