Effectiveness of Physiotherapy for Improving Functionality, Participation and Quality of Life After a Stroke: Single-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Perception of quality of life
研究概览
简要总结
The World Health Organization (WHO) defines Stroke or Cerebrovascular Accident as clinical sign of focal disorder in brain functioning of rapid onset, with a presumed vascular origin and duration of more than 24 hours. It represents the first cause of physical disability in adults, and approximately half of people who survive stroke present motor and sensitivity disorders, which cause alterations in functionality, especially in activities of daily living, with the consequent impact negative in participation in the environment and the quality of life of people and their families.
The objective of the study is to know the effectiveness of a Physiotherapy intervention, based on the achievement of objectives, in improving functionality, participation and quality of life after a Stroke compared to treatment protocol.
Methodology: single-blind randomized controlled clinical trial. The sample of 62 subjects (31 in each group) will be recruited at the Ramon y Cajal University Hospital. The Physiotherapy intervention will consist of 30 sessions, 3 times/week, for 10 consecutive weeks, in which the treatment for the Experimental Group will be based on training of specific tasks aimed at functional objectives previously agreed upon with the person/user vs. the Control Group who will receive a conventional Physiotherapy treatment protocol. The outcome variables are: perception of quality of life (Spanish version of The Newcastle Stroke-specific Quality of Life Measure); degree of functional disability (Barthel Index); level of gait functionality (Spanish version of Functional Ambulation Categories); dynamic balance and trunk control (Spanish version of Trunk Impairment Scale); postural control (Spanish version of the Postural Assessment Scale for Stroke Patients); and participation in the environment (Spanish version of the Oxford Participation and Activities Questionnaire). They will be collected at three times: before starting the study, initial assessment (V0), at the end of the intervention for each group, intermediate assessment (V1) and 6 months after V0 (V2).
详细描述
Background:
According to the WHO, stroke represents the first cause of physical disability in the adult population, as well as the second cause of death in industrialized and developed countries, becoming a pathology of great socioeconomic cost. The number of people suffering from stroke, worldwide, has increased considerably in recent decades, especially since the beginning of the global pandemic, presenting itself as a complication of COVID19. In Spain, the incidence of stroke ranges between 150 and 323 cases per 100,000 inhabitants. Its frequency increases with age, especially in the population over 65 years of age, and it is considered that after six months of having suffered a stroke, 26.1% of people die, 41.5% of those affected are independent, and 32.4% have some type of functional dependency.
Among the most frequent sequelae, motor impairment stands out, which is usually considered the main cause of disability in people due to its impact on balance, causing gait disorders and an increased risk of falls, as well as difficulty in handling and performance of activities of daily living (ADL). When these alterations persist over time, they not only hinder functionality but also interfere with the interaction with the environment and the subject's participation in social activities, negatively affecting the perception of their quality of life. This is why Physiotherapy interventions that include training in functional activities are an optimal approach strategy. Recently, based on the International Classification of Functioning, Disability and Health, a paradigm shift is occurring in the treatment of the functionality of people who have suffered a stroke. The European Stroke Organization indicates that during motor recovery, patients learn to optimize their motor, sensory and cognitive functioning through repetitive, goal-oriented, progressive and task-specific training. And here it is worth highlighting the importance of the functional orientation of physiotherapy to help these people maximize health, well-being and quality of life.
Physiotherapy treatment after stroke carries a high cost as it requires specialized personnel in a multidisciplinary team because it is a long-term individualized therapy. Instead of limiting ourselves to teaching compensation methods to recover mobility, motor control and lost balance, it has been proposed to focus on the nervous system's ability to recover previous movement patterns, through functional use and neuroplasticity. Establishing functional goals could be the key to effective decision making, as well as a person-centered outcome measure for Stroke rehabilitation. Based on all this, we consider that the Physiotherapy intervention should be based on the needs of the person instead of pre-established treatment designs.
The latest systematic reviews carried out show that the impact of methodologies based on functionality compared to conventional treatments has not yet been rigorously evaluated. Optimizing physiotherapy treatment would allow us to improve the patient's level of recovery after a stroke, reducing dependency rates and increasing their quality of life, while reducing the number of sessions necessary and the waiting list to access treatment.
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
Single-blind, parallel, randomized controlled clinical trial, allocation ratio 1:1 and with third-party evaluation.
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with stroke between 6 and 24 months before the intervention.
- •Age 50 or more years.
- •Have signed the informed consent.
排除标准
- •Present moderate or severe cognitive impairment according to the Pfeiffer Questionnaire.
- •Have other serious diseases with a significant impact on functional capacity.
- •Suffer previously diagnosed psychiatric pathology.
- •Being dependent for activities of daily living before suffering the stroke.
研究组 & 干预措施
intervention group (EG)
The participants will receive as a therapeutic approach 3 physical therapy sessions/week of 40' duration, for 10 weeks.
干预措施: Approach by functional objectives (Other)
control group (CG)
The participants will receive as a therapeutic approach 3 physical therapy sessions/week of 40' duration, for 10 weeks.
干预措施: Treatment protocol (Other)
结局指标
主要结局
Perception of quality of life
时间窗: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
Spanish version of NewsQoL
Functional disability
时间窗: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
Barthel index
Participation in the environment
时间窗: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
Spanish version Oxford Participation and Activities Questionnaire
次要结局
- Postural control(Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.)
- Dynamic balance and trunk control(Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.)
- Level of gait functionality(Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.)
研究者
Concepción Soto-Vidal
Degree Teacher in Physiotherapy
University of Alcala
