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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Not yet enrolling

Conditions: Stroke

Treatments: Other: Home-Based Therapeutic Exercise - Telerehabilitation Group; Other: Home-Based Therapeutic Exercise - Document Group; Other: Standard Care Guidance Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06944197

24/190-P

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups, including a placebo group

Guiding Document Group

Placebo Comparator group

Description:

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

Treatment:

Other: Standard Care Guidance Group

Therapeutic Exercises Document Group

Active Comparator group

Description:

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.

Treatment:

Other: Home-Based Therapeutic Exercise - Document Group

Telerehabilitation Group

Experimental group

Description:

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.

Treatment:

Other: Home-Based Therapeutic Exercise - Telerehabilitation Group