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IctusFV-CPNCT07811843

Effectiveness of Laser Visual Feedback in Postural Control After a Stroke

A study testing Intervention in people with Ictus and Convalescence, run by Parc Sanitari Pere Virgili at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
1 Jan 2028to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ana M Barrios Franquesa, PhD contact

+ 34 932 594 307

abarrios@perevirgili.cat

Spain1 site
  • Parc Sanitari Pere Virgili

    Barcelona, Barcelona, 08023

    Ana M Barrios, PhD, 932 594 307, abarrios@perevirgili.cat

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Intervention
Medical subject headings
Convalescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionOther

    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.

Study groups in NCT07811843
Study groupRoleWhat they receive
ControlNo interventionThe control group will receive the center's usual care, as described above, consisting of 30-minute sessions of physiotherapist's exercise.
InterventionalExperimentalNot described
Receives: Other: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance

    Postural Assessment Scale for Stroke Patients (PASS). This scale evaluates postural control in individuals with stroke, particularly during the early stages of recovery.

    Measured: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.

  2. 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.

    Measured: It will be measured at baseline assessment and at final assessment at 30 days.

Secondary outcomes (3)
  1. 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.

    Measured: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.

  2. 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.

    Measured: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.

  3. 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.

    Measured: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Jan 2028 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
As participants are enrolled in the study, they will be randomly assigned to either the experimental group or the control group. 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. Participants will be randomly assigned to one of the two study groups: the control group (CG) or the experimental group (EG). Prior to the initiation of any intervention, a baseline assessment (T0) will be conducted. Subsequently, a follow-up assessment will be performed at 15 days (T1), and a final assessment will be conducted at 30 days (T2). All outcome measures will be assessed at baseline (T0) and at the end of the intervention period (T2).
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811843
Sponsor's protocol ID
FV-CP
Acronym
FV-CP
Status last verified
Sep 2026
First submitted
31 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Ictus and Convalescence, run by Parc Sanitari Pere Virgili at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ana M Barrios Franquesa, PhD (+ 34 932 594 307, abarrios@perevirgili.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance (time frame: It will be measured at baseline assessment, at 15 days' visit and at final assessment at 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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