About this trial
Background: Stroke is one of the leading causes of acquired disability and frequently results in impairments in balance and postural control that affect functional independence. Rehabilitation during the subacute phase is crucial for promoting neurological recovery. Visual feedback using a laser device may facilitate motor learning and postural correction; however, its effectiveness in individuals with subacute stroke has been insufficiently investigated.
Objectives: To evaluate the effectiveness of a laser-based visual feedback exercise program in improving postural control in individuals with subacute stroke. Secondary objectives are to assess its impact on balance, mobility, and functional performance, and to compare outcomes with those achieved through conventional rehabilitation.
Methods: A randomized controlled trial will be conducted in individuals with subacute stroke. Participants will be randomly assigned to either an intervention group, receiving exercises with laser-based visual feedback, or a control group, receiving usual rehabilitation care. Pre- and post-intervention assessments will be performed using validated instruments to measure postural control, balance, and functional capacity.
Discussion: This study addresses the need to identify effective, accessible, and low-cost therapeutic strategies to optimize post-stroke rehabilitation. If proven effective, laser-based visual feedback could enhance functional recovery, promote greater independence in activities of daily living, and help reduce the long-term impact of disability. The findings will provide scientific evidence relevant to clinical practice and may support the incorporation of this approach into neurological rehabilitation programs. In addition, the project will generate valuable knowledge for future research on innovative feedback-based strategies to improve functional recovery following stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older admitted from an acute care hospital to a convalescence, rehabilitation, or intermediate care unit for functional recovery following a stroke.
Diagnosis of ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).
Ability to tolerate assisted standing for a minimum of 10 seconds.
Hemodynamically stable individuals, free from fever and disabling pain
Disqualifiers
Severe pre-stroke functional dependency, defined as a Barthel Index (BI) score ≤ 60.
Diagnosis of dementia with a score ≥ 4 on the Global Deterioration Scale (GDS).
Spasticity assessed with the Modified Ashworth Scale (MAS) ≥ 2.
Diagnosis of acute confusional syndrome or delirium.
Trial design
Parallel
Treatments tested in this trial
Intervention
Other interventionThe experimental group will receive conventional physiotherapy treatment two days per week and a laser-based visual feedback exercise program three days per week, with each session lasting 30 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Balance
Postural Assessment Scale for Stroke Patients (PASS). This scale evaluates postural control in individuals with stroke, particularly during the early stages of recovery.
Segmental body alignment analysis
Spinal alignment and immediate postural sway during sit-to-stand transition using a low-profile inertial measurement unit (IMU)-based postural monitoring system that mesures inclination angles in the sagittal, frontal, and transverse planes through two sensors placed at the thoracic and lumbar regions.
Secondary outcomes
Gait Ability
Assess through the Functional Ambulation Classification (FAC). This scale classifies walking ability on a scale from 0 to 5, ranging from complete inability to walk to independent ambulation on all surfaces. In addition, the GAITRite® system will be used to analyze spatiotemporal gait parameters, including gait speed, cadence, step length, gait symmetry, base of support, and other indicators related to gait quality.
Risk of falls
Assess using the Tinetti Performance-Oriented Mobility Assessment. This tool evaluates balance (16 points) and gait (12 points), with a maximum score of 28 points.
Upper limb functional capacity
Assessed using the Stroke Upper Limb Capacity Scale (SULCS). This instrument evaluates upper limb function through 10 hierarchical tasks related to activities of daily living. Scores range from 0 to 10, with higher scores indicating better functional capacity.
Other outcomes
Sociodemographic data
Age, sex, handedness, social and family support, previous employment status, educational level, and discharge destination
Stroke severity
Stroke severity assessed using the National Institutes of Health Stroke Scale (NIHSS).
Walking ability Pre-stroke
Walking ability assessed using the Functional Ambulation Classification (FAC)
Level of independence in activities of daly living Pre-stroke
Level of independence in activities of daily living measured with the Barthel Index.
Sponsors and contacts
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