Effectiveness of Physiotherapy After Stroke

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).

Conditions

• Stroke

Interventions

OTHER

Approach by functional objectives

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.

OTHER

Treatment protocol

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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• University of Alcala

  lead OTHER

Principal Investigators

• Concepción Soto-Vidal · University of Alcala

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-12

Primary Completion

2025-04-30

Completion

2026-10-31

Countries

• Spain

Study Locations