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

NCT06944197 | Not Yet Recruiting

• 1 other identifier: 24/190-P
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Keywords

Chronic disease; Primary Care; Therapeutic exercises; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Level of dependence or functional capacity in activities of daily living (ADLs)

  The primary variable is the degree of dependence or functional capacity in activities of daily living (ADLs), which is assessed using the Barthel Index . This validated scale was also used for sample size calculation. The Barthel Index is a simple, reliable, and valid tool that can detect changes in functional status and is easy to interpret. Despite some limitations, it is widely recommended as a preferred measure for assessing physical disability, both in clinical practice and in epidemiological research and public health. The scale ranges from 0 to 100, where a score of 100 represents complete independence, meaning the person can perform all daily activities without assistance. On the other hand, a score of 0 indicates complete dependence, meaning the person requires full help with these activities. Essentially, higher scores on the Barthel Index reflect better functional independence.

  From recruitment to the end of treatment at 10 weeks.

Secondary Outcomes (11)

• Upper and lower limb motor function

  From recruitment to the end of treatment at 10 weeks.

• Upper and lower limb muscle tone

  From recruitment to the end of treatment at 10 weeks.

• Upper amb lower limb muscle strength

  From recruitment to the end of treatment at 10 weeks.

• Postural Balance

  From recruitment to the end of treatment at 10 weeks.

• Walking speed and gait performance

  From recruitment to the end of treatment at 10 weeks.

Study Arms (3)

Guiding Document Group

PLACEBO COMPARATOR

Participating subjects receive a stroke management guide document, as well as guidelines for the promotion and prevention of health of importance after a stroke.

Other: Standard Care Guidance Group

Therapeutic Exercises Document Group

ACTIVE COMPARATOR

The document "Document Therapeutic Exercise Program for the home" will be explained and delivered, which contains an exercise program to be carried out during the next 10 weeks, with a frequency of 3 times a week.

Other: Home-Based Therapeutic Exercise - Document Group

Telerehabilitation Group

EXPERIMENTAL

An individualized program of therapeutic exercises will be carried out through a Telerehabilitation platform (Physitrack) during the next 10 weeks, with a frequency of 3 times a week.

Other: Home-Based Therapeutic Exercise - Telerehabilitation Group

Interventions

Standard Care Guidance Group OTHER

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 Families, and Caregivers", published in 2022 by the Department of Health of the Generalitat de Catalunya in collaboration with the Stroke Foundation. This group serves as the control group, as the intervention closely resembles the standard care currently implemented across Primary Care Centers in Catalonia for individuals in the chronic phase of stroke recovery.

Guiding Document Group

Home-Based Therapeutic Exercise - Document Group OTHER

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 detailed instructions to ensure proper execution, including dosage specifications such as repetitions, sets, and load. A checklist template is also included to help participants track their progress and completed activities. The exercise program consists of strength exercises targeting the major muscle groups of the lower extremities (LE), upper extremities (UE), and trunk; stretching exercises focused on the most relevant flexor muscles of the lower and upper extremities; and exercises aimed

Therapeutic Exercises Document Group

Home-Based Therapeutic Exercise - Telerehabilitation Group OTHER

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 will be given during the consultation to ensure familiarity with the tool. The program mirrors the Therapeutic Exercise Document Group program, but with weekly progress monitoring via the platform. This allows the physiotherapist to adjust exercises or load based on progress. The platform also enables direct communication between participants and the physiotherapist, offering continuous support throughout the intervention.

Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

MeSH Terms

Conditions

Stroke; Chronic Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind study. The research staff who carry out the evaluations will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Physiotherapist

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: May 8, 2025
• Primary Completion: November 15, 2025
• Study Completion (Estimated): May 3, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share