An interventional study of Dual-Task Perturbation & Computerized Cognitive Training and Single-Task Perturbation-Based Balance Training in Stroke, sponsored by Matia Foundation. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Matia Foundation · Not applicable, Interventional, and Treatment
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.
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.
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:
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).
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:
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.
VARIABLES AND EVALUATION TOOLS The following variables will be collected at baseline to characterize the study population and evaluate potential confounding factors.
Sociodemographic Variables
The Neuropsychiatric Inventory (NPI) will be used to assess:
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).
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 80 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Matia Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Dual-Task Perturbation & Computerized Cognitive 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.
Other: Single-Task Perturbation-Based Balance Training
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
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.
Berg Balance Scale, BBS
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).
Time frame: Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Short-Term and Working Memory
* 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.
Time frame: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention.
Time Up and Go (TUG)
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.
Time frame: 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)
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.
Time frame: 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
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
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Hamilton Depression Rating Scale (HDRS)
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
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Hamilton Anxiety Rating Scale (HAM-A / HARS)
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
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Ashworth Scale (AS)
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.
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Brunnstrom Stages of Motor Recovery
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).
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Stroke-Specific Quality of Life Scale (ECVI-38)
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.
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Functional Independence Measure (FIM)
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).
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Sit to stand up test
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.
Time frame: Baseline, 12 weeks into intervention, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Montreal Cognitive Assessment (MoCA)
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)
Time frame: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention.
UD Interference Test
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
Time frame: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention
Trail Making Test (TMT Parts A and B)
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.
Time frame: Baseline, end of rehabilitation at 16 weeks, and 6-month follow-up post-intervention
Mini-Mental State Examination (MMSE)
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
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Functional Independence (Barthel Index)
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)
Time frame: Baseline, end of rehabilitation at 16 weeks, 6-month and 12 month follow-up post-intervention.
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 35 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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