Effects of Home Rehabilitation of Balance Based on Functional Exercises in People With Parkinson's Disease: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Mean swept area of the Centre of Pressure (COP) during the functional motor balance test (Romberg test with an arms task)
研究概览
简要总结
Balance rehabilitation programs in people with Parkinson's disease (PD) that include functional exercises, i.e. using tasks of daily living in training, show improvements in variables related to balance and gait. In previous studies, the advantage of taking into account the specificity of the task and the inclusion of specific objectives for the motor rehabilitation of people with PD has been observed. The interventions with the best results are usually carried out in hospital centers or rehabilitation gyms and, in groups of people.
Due to the situation experienced since last March 2020, due to the Covid-19 pandemic, group rehabilitation programs have been affected, especially in those pathologies that involve older age groups such as PD. For this reason, the need to transfer therapies to the home is considered, as well as to make people aware of the importance of continued rehabilitation, even from other settings. In the present study, we propose a rehabilitation program at home for people with Parkinson's disease based on balance with functional exercises, which will be compared with a home control group of people with PD that stay at home without any physical rehabilitation, and a conventional group physiotherapy program carried out in a rehabilitation gym in groups of 6 people. The effects of the experimental intervention and the control groups will be evaluated on outcomes related to balance using a dynamometric platform and outcomes related to gait through 3D photogrammetry.
详细描述
I. Objectives and Hypothesis
General objective: To determine if the effects of home rehabilitation of functional balance on the biomechanics of balance and gait, quality of life, cognitive status, and general physical performance are greater than the effects observed from the daily life activities at home, and from a conventional face-to-face group physiotherapy program.
Specific objectives:
- To analyze the intra- and inter-rater reliability of the balance assessment in people with PD with dynamometric platforms performing functional tasks of daily life.
- Determine the balance performance of people with PD in functional tasks before starting a physical therapy program.
- Compare the immediate effects observed of the functional exercise-based rehabilitation program with the evaluated effects of a group rehabilitation program and with control participants staying at home without physical therapy.
- Compare the observed medium-term effects (8-weeks) of the functional balance rehabilitation program with the observed medium-term effects of the conventional group physiotherapy program and with control participants who remain at home without a physiotherapy program.
- Analyze the influence of the severity of the disease, using the Hoehn and Yahr scale and the Unified scale of Parkinson's disease, on the effects of the home rehabilitation program based on functional exercises.
II. General procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To present diagnosis of idiopathic Parkinson's disease
- •To have H&Y stage between I and IV
- •To perform independent gait with or without technical assistance
- •To have stable parkinsonian medication for at least 1 month prior to the start of the intervention.
排除标准
- •To have other diseases that affect balance or walking
- •To present other diagnosed neurological pathologies
- •To present chronic uncontrolled diseases
- •To participate in another physical rehabilitation program during the intervention period or 1 month before starting it
- •To unknow one of the two official languages of the Valencian Community (Spain).
结局指标
主要结局
Mean swept area of the Centre of Pressure (COP) during the functional motor balance test (Romberg test with an arms task)
时间窗: 4 months
Area in which the participant sway occurs on the dynamometric platform, calculated by the movement of the COP from the start of the test to the end of it (mm2). During the motor functional test, the patient maintains balance while performing a task with the upper limbs below 90º of shoulder flexion.
次要结局
未报告次要终点
研究者
Constanza San Martín
Associate professor
University of Valencia