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The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepping training
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Learning, Practice

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Training "off" medication

Training "on" medication

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)

Full Information

First Posted
October 29, 2015
Last Updated
February 19, 2018
Sponsor
University of Utah
Collaborators
American Parkinson's Disease Association, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02593812
Brief Title
The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
Official Title
The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
May 11, 2017 (Actual)
Study Completion Date
May 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
American Parkinson's Disease Association, Inc

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Learning, Practice

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training "off" medication
Arm Type
Experimental
Arm Description
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
Arm Title
Training "on" medication
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Stepping training
Intervention Description
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.
Primary Outcome Measure Information:
Title
General task performance (response time of the random sequence) at initial retention, adjusted for baseline
Description
Response time of the random sequence within initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)
Time Frame
Day 8 (i.e. 48 hours after the last block of training)
Title
Implicit sequence learning (difference in response time between the random and repeated sequences) at initial retention, adjusted for baseline
Description
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)
Time Frame
Day 8 (i.e. 48 hours after the last block of training)
Secondary Outcome Measure Information:
Title
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in general task performance, adjusted for baseline
Description
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)
Time Frame
Day 5, Day 8 (i.e. 48 hours after the last block of training)
Title
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in general task performance, adjusted for baseline
Description
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)
Time Frame
Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
Title
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
Description
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)
Time Frame
Day 5, Day 8 (i.e. 48 hours after the last block of training)
Title
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
Description
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)
Time Frame
Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
Title
Four Square Step test score, adjusted for baseline
Description
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)
Time Frame
Day 13-15 (i.e. at least 7 days after the last block of training)
Title
MiniBEST score, adjusted for baseline
Description
MiniBEST score at delayed retention, adjusted for baseline (MiniBEST score at baseline, i.e. 3 days prior to the first block of training)
Time Frame
Day 13-15 (i.e. at least 7 days after the last block of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serene S Paul, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease

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