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"Experimental Study on Stroke Rehabilitation Based on Dual-Task Exercises"

28 ottobre 2026 aggiornato da: Karol Machiñena, Matia Foundation

This study will evaluate whether adding computerized cognitive exercises to perturbation-based balance training improves balance and other recovery outcomes in adults who have experienced a stroke within the previous two months. Participants, reside in the Donostialdea catchment area, and are referred to our outpatient neurorehabilitation unit by the Basque Health Service (Servicio Vasco de Salud), will be randomly assigned to one of two groups, Both groups will receive rehabilitation including perturbation-based balance training using the BalanceTutor system.

Participants in the experimental group will also complete computerized cognitive exercises using NeuronUP at the same time as balance training. The primary outcome is balance performance measured with the Berg Balance Scale. Other assessments will examine mobility, cognitive performance, functional independence, emotional symptoms, frailty, and quality of life. Assessments are planned at baseline, during treatment, at the end of treatment, and during follow-up (6 and 12 months follow ups).

The study will be conducted at the Neurorehabilitation Unit of Bermingham Hospital ( Matia Fundazioa), located in Donostia-San Sebastian, Spain.

Expected Impact. The expected outcomes of this project aim to provide scientific evidence on the efficacy of a dual-task intervention in the evolutionary prognosis of subacute stroke.

Panoramica dello studio

Descrizione dettagliata

  1. BACKGROUND AND CURRENT STATUS OF THE TOPIC In the context of physical and cognitive rehabilitation, the Dual-Task (DT) paradigm is defined as the simultaneous execution of two tasks that have independent goals. Generally, these tasks consist of a primary motor task (such as walking or maintaining balance) performed concurrently with a secondary task, which can be cognitive (mental arithmetic, verbal fluency) or motor (carrying an object).

    Stroke survivors often lose the "automaticity" of movement. Consequently, tasks that were once subconscious now require high levels of executive function and attention. When these patients encounter real-world environments-which are inherently "dual-task" in nature-they experience Dual-Task Interference (DTI). This interference manifests as a decrease in performance in one or both tasks, significantly increasing the risk of falls and limiting social reintegration.

    Recent evidence suggests that dual-task interventions may improve balance, gait performance, and functional recovery beyond traditional rehabilitation approaches. However, further evidence is required regarding the effectiveness of combining perturbation-based balance training with computerized cognitive stimulation in individuals with early subacute stroke.

  2. HYPOTHESIS Participants receiving dual-task cognitive-motor rehabilitation combining perturbation-based balance training and computerized cognitive stimulation will demonstrate superior improvements in balance performance compared with participants receiving perturbation-based balance training alone.

  3. OBJETIVES The principal objective of the study is to evaluate the effectiveness of a dual-task cognitive-motor rehabilitation programme combining Perturbation-Based Balance Training (PBT) and computerized cognitive stimulation delivered through NeuronUP on balance performance, as measured by the Berg Balance Scale (BBS), in individuals with early subacute stroke (<2 months post-onset).

    The secundary objectives are:

    • SO1. To evaluate the effect of the program on motor and functional recovery.
    • SO2. To determine the impact of the intervention on cognitive performance.
    • SO3. To analyze the impact of the intervention on quality of life, emotional state, and functional independence.
    • SO4. To assess the feasibility of the program through participant adherence, satisfaction, and safety of the intervention.
  4. METHODOLOGY The study will be conducted at the Neurorehabilitation Unit of Bermingham Hospital (Matia). Participants will include individuals who have experienced a stroke within the past two months, reside in the Donostialdea catchment area, and are referred to our outpatient neurorehabilitation unit by the Basque Health Service (Servicio Vasco de Salud).

  5. TYPE OF STUDY This information is described in detail in the corresponding section.

  6. STUDY SUBJECTS This information is described in detail in the corresponding section.

  7. SAMPLE SIZE The sample size calculation was based on the study primary outcome, the Berg Balance Scale (BBS).

    A minimum clinically important difference of 6 points on the Berg Balance Scale was considered clinically relevant between study groups.

    Published dual-task rehabilitation studies reported post-intervention BBS values of 45.5 ± 6.3 and 45.9 ± 7.2 (Song GB, Park EC. Effect of dual tasks on balance ability in stroke patients. J Phys Ther Sci. 2015 Aug;27(8):2457-60. doi: 10.1589/jpts.27.2457). Based on these data, a pooled standard deviation of 6.76 points was estimated. Assuming a clinically relevant difference of 6 points between groups, the corresponding standardized effect size was Cohen's d = 0.88.

    Using a two-sided alpha level of 0.05 and a statistical power of 90%, the minimum required sample size was estimated to be 33 participants per group.

    To account for an anticipated attrition rate of 20%, the sample size was increased to 40 participants per group.

    Therefore, the final planned sample size is 80 participants, with 40 participants allocated to the intervention group and 40 participants allocated to the control group.

    Sample size calculations were performed using G*Power software (version 3.1).

  8. DESCRIPTION OF THE INTERVENTION The rehabilitation programme consists of two sequential phases. All participants receive the same initial rehabilitation programme, while the intervention differs during the perturbation-based balance training phase.

    Phase 1. Conventional Neurorehabilitation (Pre-Intervention Phase) Following enrolment, all participants undergo individualized conventional neurorehabilitation delivered by physiotherapists and occupational therapists.

    This initial phase focuses on the recovery of mobility, muscle strength, proprioception, postural control, balance, and functional performance. Rehabilitation begins with seated exercises and progressively advances to standing activities according to each participant's functional recovery.

    The duration of this phase varies between participants and depends on their ability to achieve sufficient postural control, standing balance, and physical capacity to safely participate in perturbation-based balance training.

    Phase 2. Perturbation-Based Balance Training (Intervention Phase) Once participants demonstrate the ability to maintain an upright posture and safely tolerate standing activities, they enter the intervention phase.

    Both study groups perform perturbation-based balance training (PBT) using the Balance Tutor system. The system consists of a treadmill mounted on a moveable platform capable of generating controlled multidirectional perturbations while participants are standing or walking.

    PBT aims to improve reactive postural control, dynamic balance, and gait performance by exposing participants to unexpected external perturbations that require rapid balance corrections.

    The system includes a safety harness and emergency stop mechanisms to ensure participant safety. Training progression, perturbation intensity, and exercise difficulty are individualized according to participant performance and rehabilitation needs.

    Training duration gradually increases during the first sessions, starting with short exposure periods and progressing up to a maximum of 30 minutes of active training per session.

    Treatment Schedule The intervention programme lasts approximately 16 weeks. Participants attend two treatment sessions per week.

    Each session lasts approximately 40 minutes and consists of:

    • 5 minutes of preparation and familiarization.
    • Up to 30 minutes of active training.
    • 5 minutes of recovery and session closure. The physiotherapy and occupational therapy teams individualize exercise progression, intensity, and difficulty throughout the programme.

    Participant adherence, session attendance, progression parameters, and adverse events are recorded prospectively during the intervention period.

    Study Timeline and Assessment Schedule

    All participants undergo repeated assessments at five predefined time points:

    T0 - Baseline Assessment Before randomization and before the start of the intervention programme. Demographic, clinical, cognitive, functional, mobility, balance, and quality-of-life assessments are completed at this time point.

    T1 - Mid-Intervention Assessment Twelve weeks after initiation of the intervention programme. This assessment is designed to evaluate intermediate treatment effects on balance, cognition, mobility, and functional status.

    T2 - Post-Intervention Assessment At completion of the intervention programme. This represents the primary post-treatment evaluation and will be used to determine the immediate effectiveness of the intervention.

    T3 - Six-Month Follow-Up Six months after completion of the intervention programme. This assessment evaluates the maintenance of treatment effects over time. T4 - Twelve-Month Follow-Up Twelve months after completion of the intervention programme. This final assessment evaluates the long-term sustainability of treatment benefits on balance, cognitive performance, mobility, functional independence, and quality of life.

    All primary and secondary outcome measures will be collected at T0, T1, T2, T3, and T4 unless otherwise specified. Participant satisfaction will be assessed exclusively at T2 following completion of the intervention programme.

  9. VARIABLES AND EVALUATION TOOLS The following variables will be collected at baseline to characterize the study population and evaluate potential confounding factors.

    Sociodemographic Variables

    • Age
    • Sex
    • Marital status
    • Educational level
    • Living arrangement
    • Occupational history
    • Place of residence Clinical Variables
    • Type of stroke (ischemic or hemorrhagic)
    • Time since stroke onset
    • Presence of recognized disability
    • Weight
    • Height
    • Body Mass Index (BMI) Pharmacological Variables
    • Number of medications
    • Medication classes
    • Psychotropic Burden Index (PBI) Comorbidity and Health Status
    • Charlson Comorbidity Index (CCI)
    • Visual impairment
    • Hearing impairment
    • Urinary incontinence
    • Fecal incontinence
    • Constipation
    • Pressure ulcers
    • Physical immobility
    • Dysphagia
    • Delirium
    • Affective disorders Neuropsychiatric Symptoms

    The Neuropsychiatric Inventory (NPI) will be used to assess:

    • Delusions
    • Hallucinations
    • Agitation
    • Depression
    • Anxiety
    • Apathy
    • Irritability
    • Sleep disturbances
    • Abnormal motor behaviour The outcome measures are described in a separate section
  10. STATISTICAL ANALYSIS For data entry and management, REDCap (Research Electronic Data Capture) will be utilized. Statistical analyses will be performed using STATA and R (version 4.2.3 or higher).

Primary Analysis: Linear Mixed-Effects Models. To evaluate the effect of the intervention over time (T0 vs. T1) and differences between study arms (Intervention Group vs. Control Group), Linear Mixed-Effects Models (LMM) for repeated measures will be fitted.

Fixed Effects: The model will include "Group" (Intervention/Control), "Time" (T0/T1), and, critically, the Group and Time interaction term. The primary interest of the study lies in the statistical significance of this interaction term, which will test whether the trajectory of cognitive, functional, and clinical variables over time differs between groups.

Random Effects: A random intercept for "Participant" will be included to account for inter-individual variability and the intrinsic correlation of repeated measures within the same subject.

Secondary and Complementary Analyses. To complement the primary model and facilitate the clinical interpretation of changes, the following analyses will be conducted:

Intragroup Comparison (Pre-Post Evolution): To assess net changes within each study arm between T0 and T1, paired t-tests will be applied for normally distributed variables. If normality assumptions are violated, the non-parametric Wilcoxon signed-rank test will be used.

Intergroup Comparison (Magnitude of Change): Change scores (Δ=T1-T0) will be calculated for each variable. Differences in the magnitude of change between the control and intervention groups will be analyzed using independent-samples $t$-tests or Mann-Whitney $U$ tests, as appropriate.

Effect Size: To quantify the clinical relevance of the findings, effect sizes will be calculated using Cohen's d (for parametric contrasts) or Rosenthal's r (for non-parametric contrasts), interpreted as small (0.2), medium (0.5), or large (0.8).

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • GUIPUZCOA
      • San Sebastián, GUIPUZCOA, Spagna, 20018

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Clinical diagnosis of stroke (ischemic or hemorrhagic) with a time since onset of two months or less at the baseline assessment.

Exclusion Criteria:

  • Neurological Comorbidity: Concurrent diagnosis of any prior or concomitant neurological disorder.
  • Significant Cognitive Impairment: Patients scoring below 24 points on the Mini-Mental State Examination (MMSE).
  • Cognitive or Comprehension Limitations: Diagnosis of borderline intellectual functioning or the presence of severe language/comprehension impairments.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dual-Task Perturbation & Computerized Cognitive Training

Participants allocated to the intervention arm will receive a combined cognitive-motor dual-task rehabilitation protocol combining Perturbation-Based Balance Training (PBT) delivered simultaneously with computerized cognitive stimulation via the NeuronUP online neurorehabilitation platform.

The motor component consists of structured treadmill- or platform-based postural perturbational challenges designed to evoke reactive balance responses. Concurrently, participants will perform computerized cognitive exercises displayed on an eye-level screen targeting four core cognitive domains: memory, attention, language, and reasoning.

To ensure both standardization across subjects and individualized progression, participants will execute a fixed set of five validated NeuronUP tasks during every session:

Forming Sentences. Interview. Traffic Fines. Bottle Caps. Pass the Ball

Comparatore attivo: Single-Task Perturbation-Based Balance Training

Participants allocated to the control arm will receive a single-task motor rehabilitation protocol focused exclusively on Perturbation-Based Balance Training (PBT) delivered via the BalanceTutor system.

To serve as an active comparator, participants in this group will undergo an identical motor perturbation protocol on the BalanceTutor system-matching the intensity, frequency, direction, and magnitude of postural perturbations received by the experimental group-but without any concurrent cognitive stimulation or tasks (i.e., without the NeuronUP platform). Training will be administered in individual sessions, 3 times per week, for a total duration of 16 to 24 weeks, under direct supervision of a physical therapist.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Berg Balance Scale, BBS
Lasso di tempo: Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Statistically significant improvements in functional balance recovery are expected in favor of the intervention group compared to the control group. Furthermore, a higher proportion of subjects in the experimental group is expected to achieve the Minimal Clinically Important Difference (MCID)-defined as an increase of ≥6 points on the Berg Balance Scale (BBS)-and to demonstrate a favorable transition toward lower fall-risk categories (BBS scores >41 points).

Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Short-Term and Working Memory
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention.
  • Evaluation Tool: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV), Digit Span Subtest.

  • Variable Type: Quantitative continuous / Primary secondary outcome.

  • Domain & Construct Assessed: Auditory short-term memory, focused attention, verbal working memory, and executive control in post-stroke individuals.

  • Measurement Sub-domains & Metrics:

    1. Digit Span Forward: Measures immediate auditory retention and short-term memory capacity. Metrics recorded include total raw score (correct trials) and memory span (maximum sequence length accurately repeated in direct order).
    2. Digit Span Backward: Measures working memory capacity, mental manipulation, and executive control. Metrics recorded include total raw score (correct trials) and memory span (maximum sequence length accurately repeated in reverse order).
    3. Total Digit Span Raw Score: Cumulative composite raw score combining correct trials from both Forward and Backward modalities.
Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Time Up and Go (TUG)
Lasso di tempo: Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Outcome Measure Title: Functional Mobility, Frailty, and Overall Health Status.

Variable Type: Quantitative continuous

Domain Assessed: Dynamic balance, functional mobility, gait speed, overall health deterioration, and frailty status in post-stroke individuals.

Operational Metric: Time recorded in seconds (s) required for the participant to stand up from a standard armchair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down again.

Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
10-Meter Walk Test (10MWT)
Lasso di tempo: Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

The 10-Meter Walk Test (10MWT) assesses walking speed in meters per second (m/s) over a short distance. Participants are instructed to walk along a 10-meter pathway at their [comfortable / maximum] self-selected pace. Acceleration and deceleration distances of 2 meters each are provided at the start and end of the course; only the central 6 meters are timed using a digital stopwatch. The primary outcome metric is the mean walking speed (m/s) calculated from [e.g., two / three] trials.

Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Frailty Phenotype According to Fried Criteria
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Assessment of frailty status using Fried's Frailty Phenotype model, which evaluates five criteria: unintentional weight loss (>10 lbs or >5% of body weight in the past year), self-reported exhaustion, low physical activity level, slow gait speed, and weak handgrip strength.

Participants are classified based on the number of criteria present:

Robust / Non-frail: 0 criteria met

Pre-frail: 1 or 2 criteria met

Frail: 3 or more criteria met

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Hamilton Depression Rating Scale (HDRS)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Assessment of depression severity using the [17-item / 21-item] Hamilton Depression Rating Scale (HDRS). The scale evaluates depressive symptoms including mood, feelings of guilt, suicide ideation, insomnia, work and activities, agitation, anxiety, somatic symptoms, and loss of weight.

Items are scored on either a 3-point (0 to 2) or 5-point (0 to 4) Likert scale. The total score ranges from 0 to [52 para 17 items / 66 para 21 items], with higher scores indicating greater severity of depressive symptoms.

Score interpretation (for the 17-item version):

0-7: Normal / Remission

8-13: Mild depression

14-18: Moderate depression

19-22: Severe depression

≥23: Very severe depression

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Hamilton Anxiety Rating Scale (HAM-A / HARS)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Assessment of anxiety severity using the 14-item Hamilton Anxiety Rating Scale (HAM-A). The scale evaluates both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).

Each item is scored on a 5-point Likert scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.

Score interpretation:

< 17: Mild anxiety severity

17-24: Mild to moderate anxiety severity

25-30: Moderate to severe anxiety severity

> 30: Severe anxiety

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Ashworth Scale (AS)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Assessment of muscle spasticity using the Modified Ashworth Scale (MAS). The scale measures resistance encountered during passive muscle stretching in the target muscle groups [e.g., upper/lower limb flexors or extensors].

The scale ranges from 0 to 4 across 6 scoring categories:

0: No increase in muscle tone.

1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM).

1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM.

2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.

3: Considerable increase in muscle tone, passive movement difficult.

4: Affected part(s) rigid in flexion or extension.

Higher scores indicate greater muscle spasticity.

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Brunnstrom Stages of Motor Recovery
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Assessment of motor recovery following stroke using the Brunnstrom Stages of Motor Recovery for the affected limbs [e.g., upper extremity, lower extremity, hand]. The scale evaluates the progression of voluntary movement control from reflex-dominated movement to normal voluntary function.

The scale consists of 6 sequential stages (1 to 6):

Stage 1: Flaccidity; no voluntary movement in the affected limb.

Stage 2: Basic limb synergies appear; spasticity begins to develop.

Stage 3: Voluntary control of movement synergies; spasticity reaches its peak.

Stage 4: Movement combinations out of synergy begin to develop; spasticity begins to decline.

Stage 5: More complex movement combinations learned; basic synergies lose dominance.

Stage 6: Spasticity disappears; individual joint movements become possible and coordination approaches normal.

Higher stages indicate greater motor recovery and voluntary motor control (range: 1 to 6).

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Stroke-Specific Quality of Life Scale (ECVI-38)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Assessment of health-related quality of life (HRQoL) using the 38-item Stroke-Specific Quality of Life Scale (Escala de Calidad de Vida para el Ictus - ECVI-38). The scale evaluates eight domains: Physical Function, Feelings, Communication, Cognition, Family Relationships, Social Relationships, Socio-Economic Function, and Work/Productivity.

Each item is rated on a 5-point Likert scale ranging from 1 to 5. Domain scores and the overall mean score are normalized on a scale from 0 to 100, where higher scores indicate poorer quality of life / greater impairment.

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Functional Independence Measure (FIM)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Will be utilized to evaluate functional independence, motor efficiency, and cognitive performance in daily activities. The FIM is an 18-item, 7-level ordinal scale instrument designed to assess the level of burden of care required by individuals with neurological impairments. Each item is scored from 1 (Total Assistance) to 7 (Complete Independence) . The total score ranges from 18 to 126, with higher scores indicating greater functional autonomy.

The scale is structured into two main domains and six subdomains:

Motor Domain (13 items, score range: 13-91):

Self-Care (eating, grooming, bathing, dressing upper body, dressing lower body, toileting)

Sphincter Control (bladder management, bowel management)

Transfers (bed/chair/wheelchair, toilet, tub/shower)

Locomotion (walking/wheelchair mobility, stairs)

Cognitive Domain (5 items, score range: 5-35):

Communication (comprehension, expression)

Social Cognition (social interaction, problem-solving, memory).

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Sit to stand up test
Lasso di tempo: Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Measures the time (in seconds) required for a participant to perform five consecutive sit-to-stand-to-sit cycles as quickly as possible.

Procedure: The participant starts seated on a standard armless chair (height: 43-45 cm) with arms crossed over the chest. Upon the command "Go," the timer starts and stops when the participant's buttocks touch the seat at the end of the fifth repetitio.

Clinical Relevance: assesses movement speed, motor strategy, dynamic balance, and fall risk in individuals post-stroke. A execution time exceeding >12 seconds is indicative of increased fall risk in stroke populations.

Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Montreal Cognitive Assessment (MoCA)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention.

General global cognitive function and specific executive performance will be assessed using the Montreal Cognitive Assessment (MoCA).

The MoCA is a widely validated, 30-point screening tool designed to detect mild cognitive impairment (MCI) and subtle post-stroke executive dysfunction with greater sensitivity than traditional screening instruments (such as the Mini-Mental State Examination).

Domain Architecture and Scoring

The assessment evaluates multiple cognitive domains across a total of 30 maximum points:

Visuospatial / Executive Functioning (5 points) Memory / Delayed Recall (5 points). Attention and Working Memory (6 points). Language (3 points) Abstraction (2 points) Orientation (6 points)

Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention.
UD Interference Test
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention

Cognitive processing speed, selective attention, response inhibition, and resistance to cognitive interference will be evaluated using the UD Interference Test.

The UD Interference Test is a validated, Stroop-based neuropsychological instrument specifically designed to overcome conventional visual and reading limitations. By utilizing highly contrastable, easily distinguishable colors, enlarged font typography, and a reduced administration time, this instrument minimizes sensory confounding factors such as color blindness (daltonism) or post-stroke visual/reading deficits.

The test consists of three primary conditions administered sequentially under timed constraints:

Word Reading / Word Condition Color Naming / Color:Condition Interference Condition

Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention
Trail Making Test (TMT Parts A and B)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention

Visuoperceptual processing speed, visual search, motor tracking, divided attention, and executive cognitive flexibility will be evaluated using the Trail Making Test (TMT), comprising Part A (TMT-A) and Part B (TMT-B).

The TMT is a widely accepted, standardized neuropsychological instrument highly sensitive to prefrontal cortex dysfunction, cognitive slowing, and executive impairment following post-stroke cerebrovascular accidents.

Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention
Mini-Mental State Examination (MMSE)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

The instrument evaluates cognitive integrity across six primary subscales:

Temporal and Spatial Orientation (10 points) Registration / Immediate Memory (6 points) Attention and Calculation (7 points)

Recall / Delayed Memory (3 points)

Language (8 points) Visuospatial / Constructive Praxis

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Functional Independence (Barthel Index)
Lasso di tempo: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

The Barthel Index is a widely validated, ordinal scale instrument designed to quantify the degree of physical assistance required by an individual with neurological impairment to perform essential basic ADLs (BADLs).

The standard scale evaluates 10 basic personal care and mobility tasks, scored in 5-point increments according to the level of physical assistance required (0, 5, 10, or 15 points per item):

Feeding (0, 5, 10 points) Bathing (0, 5 points) Grooming (0, 5 points) Dressing (0, 5, 10 points) Bowel Control (0, 5, 10 points) Bladder Control (0, 5, 10 points) Toilet Use (0, 5, 10 points) Transfers (Bed to Chair and Back) (0, 5, 10, 15 points) Mobility / Ambulation (0, 5, 10, 15 points) Stairs (0, 5, 10 points)

0 - 20 points Total dependence 21 - 60 points Severe dependence 61 - 90 points Moderate dependence 91 - 99 points Slight / Mild dep 100 points Complete functional independence (in BADLs)

Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: CAROLINA KAROL MACHIÑENA, MASTER, Matia Foundation

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 gennaio 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

30 gennaio 2029

Date di iscrizione allo studio

Primo inviato

28 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

3 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

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Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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