Effectiveness of Physiotherapy for Improving Functionality, Participation, and Quality of Life after a Stroke: Study Protocol for a Randomized Controlled Clinical Trial

Abstract

Background: Stroke survivors experience significant alterations in their daily functionality that has a negative impact on their functionality, participation, and quality of life. Person-centered approaches in Physical Therapy interventions that are focused on functional and meaningful goals help to minimize the impact of the alterations. Therefore, the aim of this study is to assess the effectiveness of a Physical Therapy intervention based on a goal-oriented approach with task-specific training for improving functionality, participation, and quality of life for people with Stroke. Methods: A single-blinded randomized controlled clinical trial will be developed. Adults over 50 years old diagnosed with Stroke over 6 months will be included in this study. Participants (n = 62) will be randomly allocated into two groups: The experimental group (n = 31) will receive 30 sessions, three per week during 10 weeks, of Physical Therapy sessions of goal-directed and task-specific training. The control group (n = 31) will follow the same intervention intensity of their usual Physical Therapy treatment. The primary outcome variables quality of life (NewsQol), participation (Ox-PAQ), and gait functionality (FAC) and the secondary outcome variables functional disability (BI), postural control (PASS), dynamic trunk balance (TIS), and functional goals (GAS) will be measured at baseline, after group interventions (10 weeks), and 6 months after the baseline. Statistical analyses will include repeated-measures ANOVA, Student’s t-test, or the Mann–Whitney U-test, with a 95% confidence interval and significance level of p < 0.05. Conclusion: Person-centered approaches in Physical Therapy interventions may yield better outcomes in functionality, participation, and quality of life for Stroke patients compared to standardized interventions. Trial registration: ClinicalTrials.gov: NCT06165666 (December 2023).