Therapeutic Exercise Program of Physiotherapy Using Telerehabilitation on Chronic Phase Stroke Patients

Official title

Effectiveness of a Therapeutic Exercise Program of Physiotherapy Through the Use of Telerehabilitation on Functional Capacity for Patients With Chronic Phase Stroke: Multicenter Randomized Controlled Clinical Trial.

Overview

Stroke is the main cause of physical disability in adults in Catalonia. Despite this, there is a lack of evidence on physiotherapy interventions during the chronic phase of the pathology. The objective of the study is evaluate the effectiveness of a therapeutic exercise program of Physiotherapy through the use of Telerehabilitation on functional capacity in activities of daily living in patients with stroke in chronic phase. For this purpose, the investigator conduct a multicenter randomized controlled clinical trial. A minimum of 75 participants will be recruited in three intervention groups (n=25 each group) from Primary Care Centers of the Institut Català de la Salut. The sample will be made up of people over 18 years of age with a medical diagnosis of Stroke, in a chronic phase and with physical sequelae. Research team will evaluate as the main variable the functional capacity for the management of activities of daily living (Barthel Index); as well as sociodemographic variables. Also secondary variables such as motor function (MMAS), muscle tone of affected limbs (MAS), muscle strength of affected limbs (MRC), balance (PASS), gait efficiency (WGS, 4MWT), perception of musculoskeletal pain (BPI), perception of fatigue (FSS), risk of falls (TUG), perception of quality of life (NEWSQOL), and perception of quality of life (NEWSQOL), and perception of perceived subjective change after treatment (GROC). The variables will be collected, before and after the intervention , which will consist of 30 sessions (3 sessions/10 weeks). The analysis will be using a mixed linear model (ANOVA 3X3). Significance level p\<0.05.

Interventions

• Other Standard Care Guidance Group
  Participants in this group will receive an individual, face-to-face consultation with a physiotherapist from the primary and community care service at the Primary Care Center. During the session, participants will be provided with an informational guide focused on the management of post-stroke conditions, as well as health promotion and secondary prevention strategies relevant to stroke recovery. The document provided is titled "Guide for People Affected by Cerebrovascular Disease, Their Famili
• Other Home-Based Therapeutic Exercise - Document Group
  Participants in this group will receive an individual, face-to-face consultation with a physiotherapist at the Primary Care Center. During the session, the "Home-Based Therapeutic Exercise Program" document will be explained and provided. This document outlines an exercise program to be followed over a 10-week period, with a frequency of three sessions per week. The explanatory document includes three weekly exercise charts covering a total of 30 sessions. Each session is clearly described with
• Other Home-Based Therapeutic Exercise - Telerehabilitation Group
  Participants will have an individual consultation with a physiotherapist at the Primary Care Center, where an individualized therapeutic exercise program will be explained. The program spans 10 weeks with three sessions per week (totaling 30 sessions) and is delivered through the Physitrack telerehabilitation platform. They will receive the "Guide for the Use of the Physitrack Telerehabilitation Platform", which provides all necessary information for effective platform use. A brief tutorial wil

Primary outcome measures

• Level of dependence or functional capacity in activities of daily living (ADLs) [Time frame: From recruitment to the end of treatment at 10 weeks.]

Secondary outcome measures (11)

• Upper and lower limb motor function [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Upper and lower limb muscle tone [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Upper amb lower limb muscle strength [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Postural Balance [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Walking speed and gait performance [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Gait performance [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Musculoskeletal pain perception [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Fatigue perception [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Fall risk [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Quality of life perception [Time frame: From recruitment to the end of treatment at 10 weeks.]
• Perception of subjective change post-treatment [Time frame: From recruitment to the end of treatment at 10 weeks.]

Eligibility criteria

Inclusion criteria

• Age 18 years or older
• Medical diagnosis of stroke
• Stroke condition present for more than 6 months
• Physical sequelae secondary to stroke
• Minimum score of 1 on the Medical Research Council scale for overall muscle strength of affected limbs
• Maximum score of 3 on the Modified Ashworth scale for overall muscle tone of affected limbs
• Maximum score of 4 on the Modified Rankin scale for disability
• Access to computer equipment (tablet, desktop or laptop computer, or smartphone)

Exclusion criteria

• Undergoing other non-pharmacological physical treatments for stroke sequelae improvement and/or maintenance
• Previous decreased motor functional capacity with a Barthel scale score of less than 60 points
• Cognitive and/or language barriers that hinder the understanding of informed consent and intervention
• Participation in another clinical trial during the study period that may impact the results of the variables to be evaluated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06944197 · 24/190-P

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗