Effectiveness of Telerehabilitation-Based Therapeutic Exercise on Functional Capacity in Chronic Stroke: Study Protocol for a Multicenter Randomized Controlled Trial

Abstract

Background: Stroke is the leading cause of physical disability in adults in Catalonia. Despite this, there is a lack of evidence of physiotherapy interventions on functional capacity during the chronic phase of the pathology. This multicenter clinical trial will be conducted with a sample size of 75 participants. Objectives: The objective of the study is to evaluate the effectiveness of a therapeutic exercise program in physiotherapy using telerehabilitation to optimize functional recovery and quality of life in people with chronic stroke, and to determine its impact on adherence to the exercise program. Methods: This is a multicenter randomized controlled trial. Three parallel groups will be compared, and two will undergo the same type of therapy. A control group (CG) will perform conventional intervention in primary care. There will be two experimental groups; (EG1) will perform document-guided therapeutic exercises at home and (EG2) will perform therapeutic exercises at home guided by a telerehabilitation program. The outcomes to be measured are degree of independence of a person in their activities of daily living, assessed by the Barthel Index, motor function, muscle tone of the affected limbs, muscle strength of the affected limbs, balance, gait efficiency, perception of musculoskeletal pain, perception of fatigue, risk of falls, perception of quality of life, and the perception of perceived subjective change after treatment. These outcomes will be evaluated at baseline (T0), at ten weeks (T1) (end of the intervention), and at 18 weeks (T2). The study duration per patient will be 18 weeks (a ten-week intervention, followed by an eight-week intervention follow-up). The analysis will be performed using a mixed linear model (ANOVA 3X3) and significance level p < 0.05.