Clinical Trial

Effectiveness of Physiotherapy After Stroke

Study acronym: EPTAS
Active, Not Recruiting
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Record status
This record was last updated May 31, 2024 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-09.
Trial Details
NCT Number NCT06165666
Lead Sponsor University of Alcala
Collaborators: Hospital Universitario Ramon y Cajal
Conditions Stroke
Enrollment 8 participants
Start Date 2024-02-12
Primary Completion 2025-04-30 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2024-05-31