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

NCT ID: NCT02593812

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-05-11

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Training "off" medication

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

Group Type: EXPERIMENTAL

Stepping training

Intervention Type: BEHAVIORAL

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.

Training "on" 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

Group Type: OTHER

Stepping training

Intervention Type: BEHAVIORAL

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.

Interventions

Stepping training

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Parkinson's Disease Association, Inc

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Serene Paul

Postdoctoral Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serene S Paul, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB_00085073

Identifier Type: -

Identifier Source: org_study_id