Effectiveness of a Therapeutic Exercise Program of Physiotherapy Through the Use of Telerehabilitation on Functional Capacity for Patients With Chronic Phase Stroke: Multicenter Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Level of dependence or functional capacity in activities of daily living (ADLs)
研究概览
简要总结
Stroke is the main cause of physical disability in adults in Catalonia. Despite this, there is a lack of evidence on physiotherapy interventions during the chronic phase of the pathology. The objective of the study is evaluate the effectiveness of a therapeutic exercise program of Physiotherapy through the use of Telerehabilitation on functional capacity in activities of daily living in patients with stroke in chronic phase. For this purpose, the investigator conduct a multicenter randomized controlled clinical trial. A minimum of 75 participants will be recruited in three intervention groups (n=25 each group) from Primary Care Centers of the Institut Català de la Salut. The sample will be made up of people over 18 years of age with a medical diagnosis of Stroke, in a chronic phase and with physical sequelae. Research team will evaluate as the main variable the functional capacity for the management of activities of daily living (Barthel Index); as well as sociodemographic variables. Also secondary variables such as motor function (MMAS), muscle tone of affected limbs (MAS), muscle strength of affected limbs (MRC), balance (PASS), gait efficiency (WGS, 4MWT), perception of musculoskeletal pain (BPI), perception of fatigue (FSS), risk of falls (TUG), perception of quality of life (NEWSQOL), and perception of quality of life (NEWSQOL), and perception of perceived subjective change after treatment (GROC). The variables will be collected, before and after the intervention , which will consist of 30 sessions (3 sessions/10 weeks). The analysis will be using a mixed linear model (ANOVA 3X3). Significance level p<0.05.
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 study. The research staff who carry out the evaluations will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Medical diagnosis of stroke
- •Stroke condition present for more than 6 months
- •Physical sequelae secondary to stroke
- •Minimum score of 1 on the Medical Research Council scale for overall muscle strength of affected limbs
- •Maximum score of 3 on the Modified Ashworth scale for overall muscle tone of affected limbs
- •Maximum score of 4 on the Modified Rankin scale for disability
- •Access to computer equipment (tablet, desktop or laptop computer, or smartphone)
排除标准
- •Undergoing other non-pharmacological physical treatments for stroke sequelae improvement and/or maintenance
- •Previous decreased motor functional capacity with a Barthel scale score of less than 60 points
- •Cognitive and/or language barriers that hinder the understanding of informed consent and intervention
- •Participation in another clinical trial during the study period that may impact the results of the variables to be evaluated
研究组 & 干预措施
Guiding Document Group
Participating subjects receive a stroke management guide document, as well as guidelines for the promotion and prevention of health of importance after a stroke.
干预措施: Standard Care Guidance Group (Other)
Therapeutic Exercises Document Group
The document "Document Therapeutic Exercise Program for the home" will be explained and delivered, which contains an exercise program to be carried out during the next 10 weeks, with a frequency of 3 times a week.
干预措施: Home-Based Therapeutic Exercise - Document Group (Other)
Telerehabilitation Group
An individualized program of therapeutic exercises will be carried out through a Telerehabilitation platform (Physitrack) during the next 10 weeks, with a frequency of 3 times a week.
干预措施: Home-Based Therapeutic Exercise - Telerehabilitation Group (Other)
结局指标
主要结局
Level of dependence or functional capacity in activities of daily living (ADLs)
时间窗: From recruitment to the end of treatment at 10 weeks.
The primary variable is the degree of dependence or functional capacity in activities of daily living (ADLs), which is assessed using the Barthel Index . This validated scale was also used for sample size calculation. The Barthel Index is a simple, reliable, and valid tool that can detect changes in functional status and is easy to interpret. Despite some limitations, it is widely recommended as a preferred measure for assessing physical disability, both in clinical practice and in epidemiological research and public health. The scale ranges from 0 to 100, where a score of 100 represents complete independence, meaning the person can perform all daily activities without assistance. On the other hand, a score of 0 indicates complete dependence, meaning the person requires full help with these activities. Essentially, higher scores on the Barthel Index reflect better functional independence.
次要结局
- Upper and lower limb motor function(From recruitment to the end of treatment at 10 weeks.)
- Upper and lower limb muscle tone(From recruitment to the end of treatment at 10 weeks.)
- Upper amb lower limb muscle strength(From recruitment to the end of treatment at 10 weeks.)
- Postural Balance(From recruitment to the end of treatment at 10 weeks.)
- Walking speed and gait performance(From recruitment to the end of treatment at 10 weeks.)
- Fatigue perception(From recruitment to the end of treatment at 10 weeks.)
- Gait performance(From recruitment to the end of treatment at 10 weeks.)
- Musculoskeletal pain perception(From recruitment to the end of treatment at 10 weeks.)
- Fall risk(From recruitment to the end of treatment at 10 weeks.)
- Quality of life perception(From recruitment to the end of treatment at 10 weeks.)
- Perception of subjective change post-treatment(From recruitment to the end of treatment at 10 weeks.)
研究者
Yaiza Casas
MSc, Physiotherapist
Institut Catala de Salut