Effectiveness of Laser Visual Feedback in Postural Control After a Stroke (FV-CP)
Efectividad de Ejercicios Con Feedback Visual Mediante láser en el Control Postural en Usuarios Con Ictus Subagudo: un Ensayo clínico Aleatorizado
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Background and Rationale
Subacute stroke is commonly associated with impairments in postural control, balance, and movement organization that directly limit functional recovery. Among these impairments, trunk control plays a central role, as it compromises the proximal stability required for maintaining sitting and standing positions, performing transfers, and generating effective motor responses. Therefore, postural control should not be viewed as an isolated rehabilitation goal, but rather as a fundamental basis for overall motor recovery. Likewise, recovery of trunk control has been linked to improvements in upper limb function, and interventions focused on proximal stabilization may enhance arm and hand performance. Taken together, these findings support the concept that optimizing postural control may facilitate both locomotor and manipulative function.
Several studies have shown that visual feedback can improve postural awareness and motor performance. However, evidence regarding the use of laser-based visual feedback in individuals after stroke remains limited. Existing studies have mainly focused on people with chronic stroke or those presenting with pusher syndrome, whereas evidence in the subacute phase is scarce. In particular, there is a lack of research involving participants who meet inclusion criteria similar to those proposed in the present study, namely individuals who are able to initiate standing with assistance. This places the project within a population with greater functional impairment that is currently underrepresented in the scientific literature.
To address this gap, a structured and progressive exercise program based on laser-guided visual feedback has been developed to improve postural control and balance in individuals with subacute stroke.
HYPOTHESES AND OBJECTIVES
Primary Hypothesis
The inclusion of a laser-based visual feedback exercise program as part of conventional physiotherapy treatment in individuals with subacute stroke improves balance.
Secondary Hypothesis
The inclusion of a laser-based visual feedback exercise program in addition to conventional treatment in hospitalized individuals with subacute stroke improves postural control, enhances gait parameters, increases upper-limb functional capacity, and reduces the risk of falls compared with individuals receiving conventional treatment alone.
Objectives
To design and validate laser-based visual feedback exercises aimed at improving balance in individuals with subacute stroke.
To evaluate whether the implementation of a laser-based visual feedback exercise program, in combination with conventional treatment, improves balance in individuals with subacute stroke.
Copilot said:
Study Design
A randomized controlled trial (RCT) will be conducted with two parallel groups (experimental and control) and single blinding of the assessor responsible for evaluating the effectiveness of the intervention. Both participants and investigators will be aware of group allocation.
Study Population
The study is aimed at individuals in the subacute phase of stroke. Procedure
All participants enrolled in the study will be admitted to the Pere Virgili Intermediate Care Hospital in Barcelona after having received care in an acute care hospital. Upon admission, participants will be immediately included in a multidisciplinary rehabilitation program tailored to their individual psychofunctional needs.
The Pere Virgili Intermediate Care Hospital provides several healthcare services, including inpatient care, outpatient care, and long-term care services. Within the inpatient setting, patients with stroke are admitted to the convalescence unit, where they receive a comprehensive rehabilitation-oriented approach. The average length of stay for these patients is approximately 38 days.
Regarding rehabilitation services, patients are assessed on the day of admission by each specialist professional involved in their care. Individuals with stroke receive five 30-minute occupational therapy sessions per week and five 30-minute physiotherapy sessions per week.
Each participant is assigned the same therapist from the initial assessment until completion of treatment. Rehabilitation is individualized according to each participant's deficits, previous functional status, and personal concerns. Physiotherapy combines traditional hands-on techniques, such as the Bobath and Perfetti approaches, with manual therapy, stretching, and massage therapy, together with motor learning-based interventions. These techniques aim to maintain joint range of motion, improve postural control and balance, and facilitate gait retraining.
Intervention Description
As participants are enrolled in the study, they will be randomly assigned to either the experimental group or the control group. Both groups will receive physiotherapy treatment five days per week for four weeks.
The control group will receive the center's usual care, as described above, consisting of 30-minute sessions. The 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.
Following the provision of written informed consent, participants will be randomly assigned to one of the two study groups: the control group (CG) or the experimental group (EG).
Before the initiation of any intervention, participants will undergo a baseline assessment (T0). Subsequently, a follow-up assessment at 15 days (T1) and a final assessment at 30 days (T2) will be conducted.
All outcome variables will be assessed at baseline (T0) and at the end of the intervention (T2). Additionally, variables related to balance (S-PASS), as well as fall risk, balance, and gait (Tinetti Scale), will also be assessed at the intermediate 15-day visit (T1).
All assessments will be conducted by a single external assessor who will receive prior training in the administration and scoring of all outcome measures used in the study. The assessor will remain blinded to participants' group allocation throughout the study in order to minimize potential assessment bias.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ana M Barrios Franquesa, PhD
- Numer telefonu: + 34 932 594 307
- E-mail: abarrios@perevirgili.cat
Lokalizacje studiów
-
-
Barcelona
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Barcelona, Barcelona, Hiszpania, 08023
- Parc Sanitari Pere Virgili
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Kontakt:
- Ana M Barrios, PhD
- Numer telefonu: 932 594 307
- E-mail: abarrios@perevirgili.cat
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Diagnosis of receptive aphasia (Wernicke's aphasia).
- Visual impairment that prevents the participant from following the laser beam used in the intervention.
- History of severe balance disorders or traumatic/orthopedic conditions that would prevent participation in the proposed rehabilitation treatment.
- Absence of balance impairment, defined as a Postural Assessment Scale for Stroke Patients (PASS) score ≥ 24 points.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Interwencyjne
|
The 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.
|
|
Brak interwencji: Control
The control group will receive the center's usual care, as described above, consisting of 30-minute sessions of physiotherapist's exercise.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Balance
Ramy czasowe: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
Postural Assessment Scale for Stroke Patients (PASS).
This scale evaluates postural control in individuals with stroke, particularly during the early stages of recovery.
|
It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
|
Segmental body alignment analysis
Ramy czasowe: It will be measured at baseline assessment and at final assessment at 30 days.
|
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.
|
It will be measured at baseline assessment and at final assessment at 30 days.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Gait Ability
Ramy czasowe: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
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.
|
It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
|
Risk of falls
Ramy czasowe: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
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.
|
It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
|
Upper limb functional capacity
Ramy czasowe: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
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.
|
It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Sociodemographic data
Ramy czasowe: At baseline assessment
|
Age, sex, handedness, social and family support, previous employment status, educational level, and discharge destination
|
At baseline assessment
|
|
Stroke severity
Ramy czasowe: At baseline assessment.
|
Stroke severity assessed using the National Institutes of Health Stroke Scale (NIHSS).
|
At baseline assessment.
|
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Walking ability Pre-stroke
Ramy czasowe: At baseline assessment.
|
Walking ability assessed using the Functional Ambulation Classification (FAC)
|
At baseline assessment.
|
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Level of independence in activities of daly living Pre-stroke
Ramy czasowe: At baseline assessment.
|
Level of independence in activities of daily living measured with the Barthel Index.
|
At baseline assessment.
|
|
Stroke characteristics
Ramy czasowe: At baseline assessment.
|
Date of the stroke event, time elapsed until the start of the intervention, type of stroke (ischemic or hemorrhagic), location according to the Oxfordshire Community Stroke Project (OCSP) classification, affected hemisphere and body side, and stroke severity assessed using the National Institutes of Health Stroke Scale (NIHSS).
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At baseline assessment.
|
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Type of stroke
Ramy czasowe: At baseline assessment.
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Type of stroke (ischemic or hemorrhagic).
|
At baseline assessment.
|
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Location of stroke
Ramy czasowe: At baseline assessment.
|
Location of stroke according to the Oxfordshire Community Stroke Project (OCSP) classification
|
At baseline assessment.
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FV-CP
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
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