Parkinson DiseaseNCT02593812
The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
A study testing Stepping training in people with Parkinson Disease, run by University of Utah at 1 site in United States.
Trial summary
The study determines whether standard medical care (dopamine) affects learning and retention of a postural stepping task in people with Parkinson's disease (PD) and whether training on a postural stepping task generalises to performance on an untrained postural task. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Stepping training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 11 May 2017
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease confirmed by neurologist
- Hoehn and Yahr stages 1 to 3
- On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
- Walks unaided
Who cannot join
- Not taking dopamine replacement therapy
- With prior surgical management for PD (e.g. deep brain stimulation)
- With medication-resistant freezing of gait
- Significant cognitive impairment (Montreal Cognitive Assessment score <18)
- Unstable medical conditions
- Other neurological conditions
- Unable to follow instructions or safely complete the training tasks
Trial locations and contacts
1 site in 1 country.
About this study
The study determines whether standard medical care (dopamine) affects learning and retention of a postural stepping task in people with Parkinson's disease (PD) and whether training on a postural stepping task generalises to performance on an untrained postural task. Half the participants will train on the stepping task after they have taken their first dose of dopamine for the day (i.e. "on" medication state) while the other half will train on the same stepping task before taking their first daily dose of dopamine (i.e. "off" medication state).
Read the detailed description
Motor learning is critical for acquiring new skills and adapting behaviour, therefore the success of rehabilitation depends on successful motor learning through practice. Motor learning involves the basal ganglia, including both the associative and sensorimotor striatum. Although people with PD are capable of motor learning, they are less efficient and do not achieve the same extent of skill acquisition and retention as people without neurological deficit.
Reductions in endogenous dopamine and reduced dopamine binding associated with loss of dopaminergic receptors due to disease progression may impair motor learning in people with PD. Conflicting evidence suggests that impaired motor learning in PD is due on the one hand to the absence of dopamine but on the other hand to "overdosing" of the basal ganglia with dopamine replacement therapy which suppresses activation of the associative striatum during the early acquisition stages of motor learning.
Understanding which factors improve or degrade motor learning of tasks will allow rehabilitation parameters to be adjusted around standard medical care in order to optimize learning and improve the efficacy of exercise interventions for people with PD. In particular, successful learning of postural tasks that challenge stability may in turn reduce falls.
- Conditions
- Parkinson Disease
- Being tested
- Stepping training
- Keywords
- Learning, Practice
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping trainingBehavioural
Participants will step rapidly to one of four cued targets. Each trial will consist of 24 steps. Participants will perform 6 blocks of 6 trials per day for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Training "off" medication | Experimental | Participants will train on the postural stepping task before taking their first daily dose of standard Parkinson's medication (dopamine), i.e. while "off" dopamine replacement medication Receives: Behavioral: Stepping training |
| Training "on" medication | Other | Participants will train on the postural stepping task after taking their first daily dose of standard Parkinson's medication (dopamine), i.e. while "on" dopamine replacement medication Receives: Behavioral: Stepping training |
What is being measured
The primary outcome is the main question the study is designed to answer.
General task performance (response time of the random sequence) at initial retention, adjusted for baseline
Response time of the random sequence within initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)
Measured: Day 8 (i.e. 48 hours after the last block of training)
Implicit sequence learning (difference in response time between the random and repeated sequences) at initial retention, adjusted for baseline
The difference in response time between the random and repeated sequences of the initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)
Measured: Day 8 (i.e. 48 hours after the last block of training)
Secondary outcomes (6)
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in general task performance, adjusted for baseline
The difference in response time of the random sequence within the initial retention trial and the last trial of acquisition, adjusted for baseline (i.e. first trial of acquisition)
Measured: Day 5, Day 8 (i.e. 48 hours after the last block of training)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in general task performance, adjusted for baseline
The difference in response time of the random sequence within the delayed retention trial and the last trial of acquisition, adjusted for baseline (i.e. first trial of acquisition)
Measured: Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in implicit sequence learning (difference in response time between the random and repeated sequences), adjusted for baseline
The difference in response time between the random and repeated sequences of the last trial of acquisition subtracted from the difference in response time between the random and repeated sequences of the initial retention trial, adjusted for baseline (i.e. first trial of acquisition)
Measured: Day 5, Day 8 (i.e. 48 hours after the last block of training)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in implicit sequence learning (difference in response time between the random and repeated sequences), adjusted for baseline
The difference in response time between the random and repeated sequences of the last trial of acquisition subtracted from the difference in response time between the random and repeated sequences of the delayed retention trial, adjusted for baseline (i.e. first trial of acquisition)
Measured: Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
Four Square Step test score, adjusted for baseline
Time taken to complete the Four Square Step test at delayed retention, adjusted for baseline (Four Square Step test score at baseline, i.e. 3 days prior to the first block of training)
Measured: Day 13-15 (i.e. at least 7 days after the last block of training)
MiniBEST score, adjusted for baseline
MiniBEST score at delayed retention, adjusted for baseline (MiniBEST score at baseline, i.e. 3 days prior to the first block of training)
Measured: Day 13-15 (i.e. at least 7 days after the last block of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJul 2016
- Primary completion11 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc
- Responsible party
- Principal investigator, Serene Paul, University of Utah
- Investigators
- Serene S Paul, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593812
- Sponsor's protocol ID
- IRB_00085073
- Status last verified
- Feb 2018
- First submitted
- 29 Oct 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02593812
- Acronym / sponsor ID
- IRB_00085073
- Conditions
- Parkinson Disease
- Keywords
- Learning, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc
- Study start
- Jul 2016 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 2 Nov 2015 (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 study determines whether standard medical care (dopamine) affects learning and retention of a postural stepping task in people with Parkinson's disease (PD) and whether training on a postural stepping task generalises to performance on an untrained postural task. Half the participants will train on the stepping task after they have taken their first dose of dopamine for the day (i.e. "on" medication state) while the other half will train on the same stepping task before taking their first daily dose of dopamine (i.e. "off" medication state).
Detailed description
Motor learning is critical for acquiring new skills and adapting behaviour, therefore the success of rehabilitation depends on successful motor learning through practice. Motor learning involves the basal ganglia, including both the associative and sensorimotor striatum. Although people with PD are capable of motor learning, they are less efficient and do not achieve the same extent of skill acquisition and retention as people without neurological deficit.
Reductions in endogenous dopamine and reduced dopamine binding associated with loss of dopaminergic receptors due to disease progression may impair motor learning in people with PD. Conflicting evidence suggests that impaired motor learning in PD is due on the one hand to the absence of dopamine but on the other hand to "overdosing" of the basal ganglia with dopamine replacement therapy which suppresses activation of the associative striatum during the early acquisition stages of motor learning.
Understanding which factors improve or degrade motor learning of tasks will allow rehabilitation parameters to be adjusted around standard medical care in order to optimize learning and improve the efficacy of exercise interventions for people with PD. In particular, successful learning of postural tasks that challenge stability may in turn reduce falls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training "off" medication | Experimental | Behavioral: Stepping trainingParticipants will train on the postural stepping task before taking their first daily dose of standard Parkinson's medication (dopamine), i.e. while "off" dopamine replacement medication |
| Training "on" medication | Other | Behavioral: Stepping trainingParticipants will train on the postural stepping task after taking their first daily dose of standard Parkinson's medication (dopamine), i.e. while "on" dopamine replacement medication |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's disease confirmed by neurologist
- Hoehn and Yahr stages 1 to 3
- On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
- Walks unaided
Key exclusion criteria (7 listed)
- Not taking dopamine replacement therapy
- With prior surgical management for PD (e.g. deep brain stimulation)
- With medication-resistant freezing of gait
- Significant cognitive impairment (Montreal Cognitive Assessment score <18)
- Unstable medical conditions
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 |
|---|---|---|
| Stepping trainingParticipants will step rapidly to one of four cued targets. Each trial will consist of 24 steps. Participants will perform 6 blocks of 6 trials per day for 3 consecutive days. | Behavioural | Training "off" medication, Training "on" medication |
Primary outcome
General task performance (response time of the random sequence) at initial retention, adjusted for baseline
Time frame: Day 8 (i.e. 48 hours after the last block of training)
Response time of the random sequence within initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)
Implicit sequence learning (difference in response time between the random and repeated sequences) at initial retention, adjusted for baseline
Time frame: Day 8 (i.e. 48 hours after the last block of training)
The difference in response time between the random and repeated sequences of the initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)
6 secondary outcomes
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in general task performance, adjusted for baseline
Time frame: Day 5, Day 8 (i.e. 48 hours after the last block of training)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in general task performance, adjusted for baseline
Time frame: Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in implicit sequence learning (difference in response time between the random and repeated sequences), adjusted for baseline
Time frame: Day 5, Day 8 (i.e. 48 hours after the last block of training)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in implicit sequence learning (difference in response time between the random and repeated sequences), adjusted for baseline
Time frame: Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
Four Square Step test score, adjusted for baseline
Time frame: Day 13-15 (i.e. at least 7 days after the last block of training)
MiniBEST score, adjusted for baseline
Time frame: Day 13-15 (i.e. at least 7 days after the last block of training)
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 22 Feb 2018.
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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.
Serene S Paul, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepping training in people with Parkinson Disease, run by University of Utah 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 4 inclusion and 7 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 22 Feb 2018. 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?
General task performance (response time of the random sequence) at initial retention, adjusted for baseline (time frame: Day 8 (i.e. 48 hours after the last block of training)). The study lists 2 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 22 Feb 2018.