Parkinson DiseaseNCT03662009
Multi-limb Dual-task Control in Parkinson's Disease
An observational study of Parkinson Disease, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial summary
People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- multilimb dual task
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals will be recruited through collaboration with hospitals, clinics, physical therapy centers, private practice physicians and physical therapists, neurology-based fitness centers, community centers, PD support groups, online trial-matching services (e.g., FoxTrialFinder.michaeljfox.org), word of mouth, and advertising. Recruitment will be limited to the greater Phoenix metropolitan area.
Who may be able to join
- have a clinical diagnosis of mild to moderate idiopathic PD (Hoehn \& Yahr stages 1-3),
- hold a valid driver's license and drive at least once a week, and
- be capable of providing informed consent and complying with study procedures. Control group participants will be healthy, neurologically intact individuals, age-matched to within 2 years of the PD subjects.
Who cannot join
- impaired global cognition (i.e., a score of < 20 on the Montreal Cognitive Assessment (MoCA) screening tool)
- sensory loss in the lower limb as assessed by clinical test of vibration perception at the ankle,
- orthopedic, visual, or neurological conditions that would prevent performance of the experimental tasks,
- inability to complete and pass the assessment testing,
- history of neurological illness such as head trauma, previous stroke, epilepsy, demyelinating disease, or
- complicating medical problems such as diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
A.T. Still University Arizona School of Health Sciences
Mesa, Arizona, 85206
About this study
Official title: Multi-limb Control in Parkinson's Disease: Implicit and Explicit Control of Attention
People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Through understanding the impact of Parkinson disease on mechanisms underlying attention and multi-limb control, training and rehabilitation programs can better focus on the needs of drivers with Parkinson disease. The proposed study aims to address this need by taking measures of simulated driving at one point in time. Subjects with PD are tested at a single time point when they are at their "best" point in their day and on another day when they are at their worst and are about to take their next dose of medication. Healthy age-matched subjects are not taking anti-parkinson medication so are tested at only one point.
- Conditions
- Parkinson Disease
- Being tested
- multilimb dual task
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multilimb dual taskOther
Also called Instructed priority, constrained accuracy
control of arm and foot in two attentional contexts of simulated driving
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Observation of individuals with idiopathic Parkinson disease performing a multilimb dual task using the arm and the leg. Receives: Other: multilimb dual task | |
| Control | Observation of healthy age-matched individuals will perform a multilimb dual task using the arm and the leg. Receives: Other: multilimb dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Task Effect on Arm and Foot Tasks
The Dual Task Effect is the performance measure of the arm and foot task, respectively, in the dual task relative to the single task, expressed as a percentage.
Measured: Subjects with PD: Two 90-minute sessions within a week; Healthy controls: One 90-minute session, observation of simulated driving.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Sep 2017
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of Idaho, Mayo Clinic
- Responsible party
- Principal investigator, Tara McIsaac, A.T. Still University of Health Sciences
- Investigators
- Tara L McIsaac, PhD, PT, Principal investigator, A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662009
- Sponsor's protocol ID
- 2017-045
- Other IDs
- 1R15NS098340-01A1
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2018
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available. Institutional infrastructure being developed.
Publications
McIsaac TL, Benjapalakorn B. Allocation of attention and dual-task effects on upper and lower limb task performance in healthy young adults. Exp Brain Res. 2015 Sep;233(9):2607-17. doi: 10.1007/s00221-015-4333-6. Epub 2015 Jun 17.
PubMed 26080755McIsaac TL, Lamberg EM, Muratori LM. Building a framework for a dual task taxonomy. Biomed Res Int. 2015;2015:591475. doi: 10.1155/2015/591475. Epub 2015 Apr 19.
PubMed 25961027Thompson T, Poulter D, Miles C, Solmi M, Veronese N, Carvalho AF, Stubbs B, Uc EY. Driving impairment and crash risk in Parkinson disease: A systematic review and meta-analysis. Neurology. 2018 Sep 4;91(10):e906-e916. doi: 10.1212/WNL.0000000000006132. Epub 2018 Aug 3.
PubMed 30076275
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-limb Control in Parkinson's Disease: Implicit and Explicit Control of Attention
- ClinicalTrials.gov ID
- NCT03662009
- Acronym / sponsor ID
- 2017-045
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of Idaho, Mayo Clinic
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 7 Sep 2018 (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.
People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Through understanding the impact of Parkinson disease on mechanisms underlying attention and multi-limb control, training and rehabilitation programs can better focus on the needs of drivers with Parkinson disease. The proposed study aims to address this need by taking measures of simulated driving at one point in time. Subjects with PD are tested at a single time point when they are at their "best" point in their day and on another day when they are at their worst and are about to take their next dose of medication. Healthy age-matched subjects are not taking anti-parkinson medication so are tested at only one point.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | Other: multilimb dual taskObservation of individuals with idiopathic Parkinson disease performing a multilimb dual task using the arm and the leg. |
| Control | – | Other: multilimb dual taskObservation of healthy age-matched individuals will perform a multilimb dual task using the arm and the leg. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals will be recruited through collaboration with hospitals, clinics, physical therapy centers, private practice physicians and physical therapists, neurology-based fitness centers, community centers, PD support groups, online trial-matching services (e.g., FoxTrialFinder.michaeljfox.org), word of mouth, and advertising. Recruitment will be limited to the greater Phoenix metropolitan area.
Key inclusion criteria (3 listed)
- have a clinical diagnosis of mild to moderate idiopathic PD (Hoehn \& Yahr stages 1-3),
- hold a valid driver's license and drive at least once a week, and
- be capable of providing informed consent and complying with study procedures. Control group participants will be healthy, neurologically intact individuals, age-matched to within 2 years of the PD subjects.
Key exclusion criteria (6 listed)
- impaired global cognition (i.e., a score of < 20 on the Montreal Cognitive Assessment (MoCA) screening tool)
- sensory loss in the lower limb as assessed by clinical test of vibration perception at the ankle,
- orthopedic, visual, or neurological conditions that would prevent performance of the experimental tasks,
- inability to complete and pass the assessment testing,
- history of neurological illness such as head trauma, previous stroke, epilepsy, demyelinating disease, or
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 |
|---|---|---|
| multilimb dual taskAlso: Instructed priority, constrained accuracycontrol of arm and foot in two attentional contexts of simulated driving | Other | Control, Parkinson Disease |
Primary outcome
Dual Task Effect on Arm and Foot Tasks
Time frame: Subjects with PD: Two 90-minute sessions within a week; Healthy controls: One 90-minute session, observation of simulated driving.
The Dual Task Effect is the performance measure of the arm and foot task, respectively, in the dual task relative to the single task, expressed as a percentage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 26080755McIsaac TL, Benjapalakorn B. Allocation of attention and dual-task effects on upper and lower limb task performance in healthy young adults. Exp Brain Res. 2015 Sep;233(9):2607-17. doi: 10.1007/s00221-015-4333-6. Epub 2015 Jun 17.
- Background: PubMed 25961027McIsaac TL, Lamberg EM, Muratori LM. Building a framework for a dual task taxonomy. Biomed Res Int. 2015;2015:591475. doi: 10.1155/2015/591475. Epub 2015 Apr 19.
- Background: PubMed 30076275Thompson T, Poulter D, Miles C, Solmi M, Veronese N, Carvalho AF, Stubbs B, Uc EY. Driving impairment and crash risk in Parkinson disease: A systematic review and meta-analysis. Neurology. 2018 Sep 4;91(10):e906-e916. doi: 10.1212/WNL.0000000000006132. Epub 2018 Aug 3.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available. Institutional infrastructure being developed.
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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.
Tara L McIsaac, PhD, PT principal investigator
A.T. Still University
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 Disease, run by A.T. Still University of Health Sciences 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 7 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dual Task Effect on Arm and Foot Tasks (time frame: Subjects with PD: Two 90-minute sessions within a week; Healthy controls: One 90-minute session, observation of simulated driving.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662009, which also lists 3 linked publications.
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 7 Feb 2022.