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临床试验/NCT03368443
NCT03368443已完成不适用

Multiple Practice Contexts to Reduce Context-dependent Learning for Gait Training in People With Parkinson's Disease

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Context-dependent learning

研究概览

简要总结

Context-dependent learning (CDL) is a phenomenon that an individual demonstrates superior motor performance in the environmental context in which a task was originally learned and practiced, while the performance may decrease if carried out in a novel context. It has often been observed that after individuals with Parkinson's disease (PD) learned how to walk in a clinical setting, they appear to have difficulty generalizing the learned walking ability back to their home or community. To date, no effective intervention approaches have been designed to resolve this CDL for people with PD. One approach that could potentially reduce CDL is to practice a motor task in multiple contexts. Learning a task in multiple contexts would make the participants less likely to rely on the inconsistent ambient contextual information, and could facilitate the generation of stronger motor program and schema. No studies to date have investigated the effects of multiple practice contexts on reducing CDL in people with PD. It is also not clear the characteristics of the participants who would benefit from this type of intervention.

This study aims to investigate the effects of gait training in multiple practice contexts on CDL in individuals with PD. Additionally, this study aims to identify the characteristics of the participants who benefit from the intervention.

Sixty-four participants diagnosed with idiopathic PD will be recruited and randomized into 2 groups: Single-room and Two-room groups. The participants will receive 45 minutes of treadmill training and 15 minutes of over-ground gait training for 12 sessions. Throughout the training sessions, the Single-room group will practice walking in the same room, while the Two-room group will receive gait training in 2 distinct rooms. All participants will be assessed by a blinded evaluator before, immediately after, and 4 weeks after the intervention. The participants will undergo a series of cognitive, motor behavior, and neurophysiological examinations.

Group × time repeated measures analysis of variance (ANOVA) and the partial eta square (η2) will be calculated to determine the intervention effects on the outcome measures. Multiple linear regression analyses will be performed to determine the demographic, cognitive and motor behavior, and neurophysiological characteristics of participants who benefit from the proposed interventions.

详细描述

Background: Recent evidence suggested that individuals with Parkinson's disease (PD) demonstrated greater context-dependency during motor learning than age-matched non-disabled adults. Context-dependent learning (CDL) is a phenomenon that an individual demonstrates superior motor performance in the environmental context in which a task was originally learned and practiced, while the performance may decrease if carried out in a novel context. It has often been observed that after individuals with PD learned how to walk in a clinical setting, they appear to have difficulty generalizing the learned walking ability back to their home or community. To date, no effective intervention approaches have been designed to resolve this CDL for people with PD.

One approach that could potentially reduce CDL is to practice a motor task in multiple contexts. Based on the research conducted with healthy young adults, learning a task in multiple contexts would make the participants less likely to rely on the inconsistent ambient contextual information. Multiple practice contexts could also facilitate the generation of stronger motor program and schema, leading to better transfer performance and less context-dependency. No studies to date have investigated the effects of multiple practice contexts on reducing CDL in people with PD. It is also not clear the characteristics of the participants who would benefit from this type of intervention.

Objectives: This study aims to investigate the effects of gait training in multiple practice contexts on CDL in individuals with PD. Additionally, this study aims to identify the characteristics of the participants who benefit from the intervention.

Methods: A total of 64 participants diagnosed with idiopathic PD will be recruited and randomized into 2 groups: Single-room and Two-room groups. The participants will receive one-on-one therapy including 45 minutes of treadmill training and 15 minutes of over-ground gait training for a total of 12 sessions. Throughout the 12 training sessions, the Single-room group will practice walking in the same room, while the Two-room group will receive gait training in 2 distinct rooms. All participants will be assessed by a blinded evaluator before, immediately after, and 4 weeks after the intervention. The participants will undergo a series of cognitive, motor behavioral, and neurophysiological examinations. Cognitive assessments will include measures of CDL, Montreal Cognitive Assessment, and the Stroop Color-Word test. Motor behavioral measures will include the Unified Parkinson's Disease Rating Scale, five times sit-to-stand test, 10-meter walk test, timed up and go test, the Activities-Specific Balance Confidence Scale, and Parkinson's Disease Questionnaire-39. Neurophysiological outcomes will be examined with transcranial magnetic stimulation to determine the changes in corticomotor excitability associated with the interventions.

Group × time repeated measures analysis of variance (ANOVA) and the partial eta square (η2) will be calculated to determine the intervention effects on the outcome measures. Multiple linear regression analyses will be performed to determine the demographic, cognitive and motor behavior, and neurophysiological characteristics of participants who benefit from the proposed interventions.

研究设计

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

入排标准

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

入选标准

  • able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)
  • able to read and hear properly without or with aids (e.g., eyeglasses or hearing aids)
  • can walk independently with or without devices

排除标准

  • has other neurological disorders in addition to PD
  • has deep brain stimulation or pacemaker implanted in their body
  • has a family-history of epilepsy
  • has a self-history of seizure
  • has unstable medical conditions

结局指标

主要结局

Context-dependent learning

时间窗: 45 mins

To evaluate context-dependent learning, a finger sequence task has been specially designed. The participants will use an enlarged keyboard to complete the designed computer finger sequence task.

10-Meter Walk Test (10-MWT)

时间窗: 5 mins

The walking ability of the participants with PD will be assessed with the 10-MWT. The participants will be instructed to walk along a 10-meter walkway in their comfortable and fastest walking speed. Gait parameters including velocity, stride length, cadence, strike angle and lift-off angle will be calculated.

The Timed Up and Go (TUG) Test

时间窗: 5 mins

The participants will initially sit on a comfortable chair with hips and knees flexed at 90°. Upon a 'GO' signal, the participants will stand up from the chair, walk for 3 meters, turn around, walk back to the chair, and sit down. The participants will be instructed to complete the task at their preferred/ comfortable speed. Good to excellent test-retest reliability and inter-rater reliability have been established in people with PD.

Activities-Specific Balance Confidence (ABC) Scale

时间窗: 5 mins

The Activities-Specific Balance Confidence (ABC) scale will be used to examine an individual's confidence level of not falling when performing activities of daily living. The ABC Scale contains 16 different activities performed indoors and outdoors. The participants will be asked to rate their confidence level (range from 0% to 100% of confidence) of not falling for each item. An average score of the 16 items (range from 0% to 100%) will be calculated to determine the participant's confidence level of not falling when performing the activities of daily living. The internal consistency and test-retest reliability of the ABC scale in patients with PD were excellent.

Corticomotor excitability

时间窗: 45 mins

Transcranial magnetic stimulation (TMS) will be used to evaluate corticomotor excitability. Corticomotor excitability outcomes will include resting motor threshold (RMT), motor evoke potential (MEP), cortical silent period (CSP) duration, short-interval intracortical inhibition (SICI), intracortical facilitation (ICF), and long-interval intracortical inhibition (LICI). The RMT could reflect the membrane excitability of the corticospinal neurons and the cortical interneurons. Peak-to-peak MEP amplitude is an indicator of the integrity and excitability of the corticospinal tract. The CSP is a period when EMG activity being suppressed for a few hundred milliseconds after the MEP, and has often been used as an indicator of the inhibitory mechanism occurs within the corticospinal tract. The SICI, ICF, and LICI have been identified to be good indicators of intracortical inhibition and facilitation.

次要结局

  • The Stroop Color-Word test(5 mins)
  • Montreal Cognitive Assessment (MoCA)(10 mins)
  • The Unified Parkinson's Disease Rating Scale (UPDRS)(10 mins)
  • Five Times Sit-to-Stand (FTSTS) Test(5 mins)
  • Parkinson's Disease Questionnaire-39 (PDQ-39)(10 mins)
  • New Freezing of Gait Questionnaire (NFOG-Q)(5 mins)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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