Clinical trial NCT06165666: Effectiveness of Physiotherapy After Stroke
Official title: Effectiveness of Physiotherapy for Improving Functionality, Participation and Quality of Life After a Stroke: Single-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
physiotherapy
clinical trial
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Ramon y Cajal
First posted: 2023-12-11
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned into 2 groups (intervention group (EG) and control group (CG)).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Objective: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.

Design: Single-blind, parallel, randomized controlled clinical trial, 1:1 allocation ratio and with third-party evaluation. The study has been approved by the Research Ethics Committee of the Ramon y Cajal University Hospital (220/23).

Study population

Inclusion criteria:

* Diagnosis of Stroke between 6 and 24 months before to study access.
* Age ≥ 50 years.
* Signing of the informed consent.

In order to detect differences in functionality, participation and quality of life in favor of the experimental group, a large effect size of d = 0.80, an error α = 0.05 and a power of 90% is assumed. Considering a possible loss to follow-up of 10%, the sample size results in 62 participants.

Methodology: participants are randomly assigned into 2 groups (intervention group (EG) and control group (CG)). All participants will receive as a therapeutic approach 3 sessions/week of 40' duration, for 10 weeks.

The therapeutic approach that will be administered to the EG will be based on the training of specific tasks aimed at functional objectives. Each session will begin with activities to activate the muscles of the trunk, pelvis and lower limbs, to modify atypical movement patterns and prepare the muscles for a more effective contraction. Subsequently, activity training will be carried out in a functional and meaningful context, aimed at specific and significant functional objectives for the participant and previously agreed upon with them. In these sessions, aspects such as postural orientation and stability, movement components and the ability to perform selective movement are taken into account.

The therapeutic approach of the participants assigned to the CG will be aimed at maintaining joint ranges and transfer work, passive mobilization of the paretic lower and upper limb, maintenance of sitting posture with/without assistance, transfer from sitting to standing, from standing to sitting. and coordination work. Subsequently, initiation of walking with a support product and/or help, if possible.

Variables: Perception of quality of life (Spanish version of The Newcastle Stroke-specific Quality of Life Measure. Degree of functional disability (Barthel Index), Functional level of gait (Spanish version of the "Functional Ambulation Categories. Dynamic balance) and trunk control (Spanish version of the Trunk Impairment Scale, Postural control (Spanish version of the Postural Assessment Scale for Stroke and Participation in the environment (Spanish version of the Oxford Participation and Activities Questionnaire. The following will also be collected: age, sex, weight, height, type of stroke, evolution time and most affected hemibody.

Data collection and analysis: data will be collected three times throughout the process: (V0), start of the study; (V1) end of intervention period and (V2), six months after the start of the study. After the measurements (V0, V1 and V2), the data will be analyzed with the Statistical Package for the Social Sciences software, version 25 for Mac.

Descriptive statistics will be performed using means and standard deviations, in the case of quantitative variables with a normal distribution, or medians and interquartile ranges, failing that. Normality will be studied using the Kolmogorov-Smirnov test. For nominal qualitative variables, absolute and relative percentage frequencies will be used.

The homogeneity of descriptive variables and initial outcome variables will be analyzed with the Student t test for independent samples (homoscedastic normal quantitative variables), with the Welch t test (non-heteroscedastic normal quantitative variables) or with the Mann-Whitney U test. (non-normal quantitative variables). In the case of nominal qualitative variables, Pearson's Chi-square test or Fisher's exact test will be used.

To study the differences between the experimental group and the control group, the Student t test for independent samples, the Welch t test or the Mann-Whitney U test will be used.

The database used in the study will be created in the RedCAP system, with the collaboration of the Ramon y Cajal Institute for Health Research Data Science Unit, a secure and structured database that allows open access to information at the institutional level, complying with Open Sciences requirements.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with stroke between 6 and 24 months before the intervention.
* Age 50 or more years.
* Have signed the informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Perception of quality of life
timeFrame: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
measure: Functional disability
timeFrame: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
measure: Participation in the environment
timeFrame: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
Secondary outcomes:
measure: Level of gait functionality
timeFrame: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
measure: Dynamic balance and trunk control
timeFrame: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
measure: Postural control
timeFrame: Beginning of the study, end of the therapeutic intervention period and 6 months after the start of the study.
Other outcomes:
measure: Cognitive impairment
timeFrame: Prior to inclusion in the study
Locations:
city: Alcalá De Henares
country: Spain
facility: Concepción Soto-Vidal
state: Madrid
Study officials:
affiliation: University of Alcala
name: Concepción Soto-Vidal
role: PRINCIPAL_INVESTIGATOR
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