Motor Learning in Parkinson's Disease: a Randomized Comparison of Integrated Versus Consecutive Dual Task Training
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Gait speed during dual task conditions (untrained Auditory Stroop task, trained Digit Span)
研究概览
简要总结
The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD). Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will not compromise safety. In the proposed study we will therefore collect high level evidence on whether 6 weeks of integrated dual task gait training is more effective than consecutive task practice. The investigators will use a randomized, single blind study design and conduct the same protocols in two academic centers (Katholieke Universiteit Leuven and Radboud Universiteit Nijmegen). The investigators intend to test an experimental condition which consists of focused dual task training in the home using a novel program of personalized cognitive tasks. The aim of dual task training is to teach motor-cognitive task integration and achieve optimal levels of automaticity and functionality. The control arm will receive gait practice and separate cognitive training of the same intensity, but offered consecutively. We will test the hypothesis that dual task training (integration) will have more pronounced effects on complex gait than consecutive task training.
Sub-analysis will be conducted on patients with and without freezing of gait. The investigators expect that integrated dual task training may be less effective in patients with freezing, due to the increased fall risk and impaired cognitive profiles.
Overall, this project will provide evidence to support future directions for motor learning and innovative rehabilitation targets.
详细描述
Purpose:
The ability to perform two or more tasks together - for instance walking and talking - is impaired in Parkinson's Disease (PD). As a result, dual tasking might evoke gait deterioration with an increased risk of falling in PD. In the European guideline for physiotherapy, it is therefore recommended to advise PD patients to avoid dual tasking. However, based on clinical experience and pilot work we argue that rather than avoiding, dual tasking should be trained and this may enhance safety.
At present, there is little clinical evidence about the effectiveness of attention-related exercise in PD. The RESCUE-trial showed sustained reductions of dual task interference after a short period of combined single and dual task cued gait training without increasing fall risk. These effects were cue-related and not contrasted with an active control group. Dual task training with a variable locus of attention showed very effective in comparison to single task training in achieving retention and transfer effects in balance-impaired older people. This randomized study also showed that dual tasking led to greater improvements of cognitive function compared to single task intervention. In addition, recent study showed dual task training to be surprisingly effective in mild to moderately affected patients with dementia, who were randomly assigned to dual tasking or unspecific exercise.
Given the positive effects of these clinical studies, the effectiveness of dual task training needs to be urgently addressed in PD patients, in whom both motor and cognitive problems are apparent. The fact that patients with freezing of gait (FOG) are associated with a surplus decline of attention and have a higher fall risk, begs the question whether dual task training is equally effective in this important clinical subgroup. Therefore, we propose to obtain high level evidence on whether dual task gait training is as effective and safe in PD-patients with FOG. The overall purpose of this project is to guide future directions for innovative rehabilitation targets.
Research objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hoehn & Yahr stage II-III in the on-phase
- •Able to walk for 10 minutes continuously
- •Dual task interference of at least 5% using a cognitive secondary task
- •Without cognitive impairment (MMSE > 24)
- •On stable medication
- •Diagnosis of Parkinson's disease made by a movement disorders specialist
排除标准
- •Deep Brain stimulation
- •Living alone
- •Severe medical conditions affecting gait
- •Hearing problems
- •Likely to change medication regimen.
结局指标
主要结局
Gait speed during dual task conditions (untrained Auditory Stroop task, trained Digit Span)
时间窗: 24 weeks
Change scores will be calculated, comparing the change over the two baseline timepoints with the change after 6 week intervention. The change between the first baseline timepoint and the last timepoint (24 weeks) will also be compared.
次要结局
- Functional Dual task, single task gait measures, cognitive outcomes, Freezing of Gait Questionnaire, Quality of life scores (PDQ39)(24 weeks)
- Fall rate as determined by weekly phonecall(24 weeks)