跳至主要内容
临床试验/NCT02593812
NCT02593812已完成不适用

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

University of Utah2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
General task performance (response time of the random sequence) at initial retention, adjusted for baseline

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Stepping training (Behavioral)

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

干预措施: Stepping training (Behavioral)

结局指标

主要结局

General task performance (response time of the random sequence) at initial retention, adjusted for baseline

时间窗: 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

时间窗: 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)

次要结局

  • MiniBEST score, adjusted for baseline(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(Day 5, Day 8 (i.e. 48 hours after the last block of training))
  • Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in general task performance, adjusted for baseline(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(Day 5, Day 13-15 (i.e. at least 7 days 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(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(Day 13-15 (i.e. at least 7 days after the last block of training))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serene Paul

Postdoctoral Research Associate

University of Utah

研究点 (2)

Loading locations...

相似试验