Effects of Gait Rehabilitation With Dual Task in Patients With Parkinson's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Velocity
研究概览
简要总结
In functional environments, dual-tasks (DT) are common and require a correct motor and cognitive performance to be carried out successfully. In people with neurodegenerative diseases such as Parkinson's disease (PD), to walk with a secondary task affects gait. The inclusion of DT to the assessment and physical rehabilitation of patients allows to simulate day-to-day contexts in a controlled and safe environment and consequently, extrapolate more easily the advances of rehabilitation to daily life.
This project studied the effects of a gait rehabilitation program with dual tasks (DUALGAIT) in patients with Parkinson's disease and compared the results with a control active group of patients who performed a general physical rehabilitation program (without dual-task and only motor exercise practice).
The investigator's hypothesis is that gait training under dual conditions has a greater effect than traditional motor physiotherapy programs on the biomechanics of parkinsonian gait.
The present study is a randomized controlled clinical trial, with evaluators blind to the allocation of participants in the different groups.
详细描述
BACKGROUND AND OBJECTIVES
In functional environments, dual-tasks (DT) are common and require a correct motor and cognitive performance to be carried out successfully. In people with neurodegenerative diseases such as Parkinson's disease (PD), to walk with a secondary task affects gait causing an alteration of velocity, stride length, cadence and double support time and therefore, greater risk of falls. In fact, patients report gait impairments as the most disabling motor symptoms of the disease. The inclusion of DT to the assessment and physical rehabilitation of patients allows to simulate day-to-day contexts in a controlled and safe environment and consequently, extrapolate more easily the advances of rehabilitation to daily life. Advantages of this kind of training are not only functional, but it could induce neuroplasticity because it is a highly challenging activity for people with PD. While the neurophysiological changes of dual-task training are not yet known, the effects of training with dual-tasks on gait seem relatively clear. Studies so far have shown that improvements of spatiotemporal parameters of DT gait can be observed in integrated and consecutive DT training, which means that the addition of cognitive tasks into gait rehabilitation, either simultaneous or consecutively, is effective. However, there is not enough evidence that DT training is better than traditional EP training, i.e., including only motor training in single-task (ST) mode. The rest of the published studies include a passive control group (i.e. group that does not perform any type of control rehabilitation) or they correspond to repeated measures studies.
Additionally, there are other methodological issues that hinder the external validity of the experiments referenced so far. Firstly, the use of the same DT, both in training and evaluation of these effects training, could prevent to observe the transfers of these effects in untrained contexts. Secondly, the use of complex secondary tasks during the assessment such as mathematical tasks or recite alphabet letters may not be representative of the DT that occur in daily life. Thirdly, the different studies included the follow-up usually one month after the training, only one study evaluated the effects beyond this time. Finally, the lack of training done in a group, it prevents knowing if training with DT is possible in a group format, as well as individually at home.
Thus, this study aims:
- To compare the short and mid-term effectiveness of a group dual-task program versus a group single-task program on biomechanics gait in people with PD.
- To analyze the effect of dual-task therapy on clinical gait variables (standardized scales and tests), cognitive performance and quality of life.
- To analyze the impact of secondary cognitive and motor tasks on single-gait before and after both physiotherapy programs.
- To compare the parkinsonian gait before and after both therapies with normal gait from matched healthy subjects.
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)
盲法说明
The physiotherapists who assessment gait before and after interventions (post and follow-up) did not know to which group each patient belonged.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of idiopathic PD
- •To present Hoehn & Yahr stadium (H & Y) I, II or III
- •Minimum of two months without any kind of physical rehabilitation.
- •To be able to walk by themselves,
- •To have a normal cognitive state according to the Minimental test adapted for PD
- •Symmetry in lower limb length (<1cm).
排除标准
- •Presence of another symptomatic neurological or musculoskeletal disease
- •History of trauma or surgery on the lower limbs
- •Balance disorders due to other diseases
- •Uncontrolled chronic diseases (e.g. hypertension or diabetes).
结局指标
主要结局
Velocity
时间窗: 20 weeks (time that includes 10 weeks of training, 8 weeks of follow-up and one week before and after the entire study to perform the Basal and Follow-up measurements)
distance travelled by the body per unit of time (m·s-1)
次要结局
- Stride length(20 weeks)
- Cadence(20 weeks)
- Double support time(20 weeks)
- Maximum hip flexion(20 weeks)
- Anterior-posterior reaction force 1(20 weeks)
- range of motion of the ankle(20 weeks)
- Maximum hip extension(20 weeks)
- Vertical reaction force 1(20 weeks)
- Vertical reaction force 2(20 weeks)
研究者
Constanza San Martín
PhD Researcher at the Department of Medicine, Associate Professor at the Department of Physiotherapy
University of Valencia