Clinical trial NCT06944197: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Chronic disease
Primary Care
Therapeutic exercises
Telerehabilitation
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Level of dependence or functional capacity in activities of daily living (ADLs)
timeFrame: From recruitment to the end of treatment at 10 weeks.
Secondary outcomes:
measure: Upper and lower limb motor function
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Upper and lower limb muscle tone
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Upper amb lower limb muscle strength
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Postural Balance
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Walking speed and gait performance
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Gait performance
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Musculoskeletal pain perception
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Fatigue perception
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Fall risk
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Quality of life perception
timeFrame: From recruitment to the end of treatment at 10 weeks.
measure: Perception of subjective change post-treatment
timeFrame: From recruitment to the end of treatment at 10 weeks.
Other outcomes:
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