An observational study in Stroke, sponsored by Azienda Unita Sanitaria Locale di Piacenza. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Observational
This study aims to evaluate the effect of a personalized technology-based rehabilitative intervention on Upper Limb (UL) motor function and capacity recovery in People with Stroke (PwS). The study is single-cohort study in which eligible participants will undergo baseline and follow-up clinical and instrumental assessments over a 4-5 week period.
The intervention consists of a personalized and specific upper limb technology-based rehabilitation programme delivered three times per week for a total of 12-15 sessions. Each session lasts approximately one hour and is integrated with conventional rehabilitation treatments.
Primary outcomes include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT). Secondary outcomes include instrumental assessment of active range of motion and grip strength.
Stroke is the second leading cause of death and the third leading cause of disability worldwide. The prevalence of upper limb motor deficits ranges approximately from 50-80% in the acute phase and from 40-50% in the chronic phase, six months after the event.
The most common upper limb impairments following stroke include paresis, altered muscle tone, reduced sensation, and loss of coordination. These deficits compromise the ability to perform activities of daily living, such as opening a door, grasping a key, or using a computer. Consequently, the recovery of upper limb motor function and capacity represents one of the primary goals of post-stroke rehabilitation.
The literature further highlights that treatment intensity, defined as a high number of repetitions, and task-oriented approaches are among the main determinants of rehabilitation effectiveness after stroke. In this context, rehabilitation technologies enable automation and intensification of treatment paradigms, improve access to therapy, and provide physiotherapists with innovative tools.
The application of these technologies in neurorehabilitation, particularly for upper limb motor recovery in adults with stroke, has led to numerous clinical studies investigating their effectiveness. Robotic rehabilitation has generally been associated with improvements in upper limb motor function. Overall, evidence indicates that technology-based interventions, such as robot-assisted therapy, virtual reality, and telerehabilitation, can enhance motor recovery when used alongside conventional treatment, particularly in individuals with moderate to severe impairments. More recent summaries of the literature further support the added value of robot-assisted approaches compared with conventional therapy alone.
Despite the growing body of evidence, several challenges remain, including population heterogeneity, variability in devices, non-standardized treatment dosage, and the lack of specific intervention parameters.
In the Italian rehabilitation landscape, rehabilitation technologies have been included in the Essential Levels of Care (LEA) of the National Health Service (SSN) since 2018 (9), promoting their adoption in clinical practice across accredited healthcare facilities. In this context, the Ausl Piacenza-Fiorenzuola Hospital represents a consolidated example of integration of technologies within rehabilitation pathways for patients with neurological conditions (e.g., stroke, spinal cord injury, traumatic brain injury). Technology-based treatments are delivered as adjuncts to conventional interventions, such as physiotherapy, hydrotherapy, occupational therapy, speech therapy, and neuropsychology, with the aim of enhancing rehabilitation effectiveness and addressing patients' functional needs.
For upper limb rehabilitation, four complementary devices are currently available:
In light of current evidence and the rehabilitation context of Fiorenzuola Hospital, the aim of this preliminary study is to evaluate the effect of a personalized technology-based treatment approach on upper limb motor function and capacity recovery in PwS.
Primary Objective The primary objective of the study is to estimate the expected effect of technology-based rehabilitation on upper limb recovery in adults with stroke.
Secondary Objective The secondary objective is to estimate technology-induced changes through instrumental assessments and explore their relationship with clinical outcomes.
Primary Endpoint The primary endpoint is the improvement in upper limb motor function and capacity, measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Action Research Arm Test (ARAT).
Clinically meaningful improvement is defined as reaching the Minimal Clinically Important Difference (MCID) of:
The secondary endpoint is the improvement in active range of motion and grasp and pinches strength, assessed instrumentally using the PABLO® system (Tyromotion, Austria).
Statistical Analysis Plan
The distributions of the variables will be tested using the Shapiro-Wilk test. Depending on the distributional properties, the data will be summarised and described using the mean and standard deviation or the median and interquartile range. To assess the comparison between measurements taken before and after the intervention, either the Student's t-test for paired samples (normal distribution) or the Wilcoxon signed-rank test (non-normal distribution) will be used. The effect size will be calculated for the FMA-UE and ARAT scales using Cohen's d. In order to explore the relationships between rehabilitation dosage and motor recovery of the upper limb, correlation tests will be carried out. In particular, the Pearson correlation coefficient (or Spearman's in the case of non-normal distributions) will be calculated between the quantitative measures of rehabilitation dose (e.g. number of sessions, total hours of treatment) and functional improvement, measured by the change in scores: (ΔFMA-UE) and (ΔARAT).
The analyses will be conducted using STATA software, with a significance level set at p\<0.05. Any missing data for the observed variables may be handled using multiple imputation.
Adult PwS admitted to the Intensive Rehabilitation Unit at Fiorenzuola d'Arda hospital. Sampling will be consecutive and carried out on the basis of feasibility and the flow of admissions to the Clinical Unit, amounting to approximately 3-5 individuals per month. The study will include PwS who meet eligibility criteria at the time of recruitment and who are able to understand and provide informed consent to participate.
Exclusion Criteria:
Adult People with Stroke (PwS) with Upper Limb (UL) motor function impairment
Device: Technology-based UL rehabilitation
Participants will receive conventional treatments, including neuromotor, occupational therapy, speech therapy and/or neuropsychology treatments, as clinically indicated. In addition, they will undergo a personalized and specific UL technology-based rehabilitation programme, delivered 3 times per week, for a total of 12 - 15 sessions. Each session will last 1 hour and will be conducted in a 1:1 format (physiotherapist : participant). Data on rehabilitation dosage will be collected, including the total number of hours of rehabilitation received. Physiotherapists who will have in charge participant, will compiled a treatment diary for each technology session in which they will record: number of session, total hour of technology-based treatments, type of device used and any adverse events.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is an ordinal scale used to assess sensorimotor function following stroke. The upper extremity motor function section includes four subscales assessing synergistic and non-synergistic movements of shoulder, elbow, wrist and hand, as well as coordination/speed. The maximum score is 66 points, indicating normal upper limb motor function. In addition to motor function, the FMA-UE assesses Non-motor domains (i.e., sensation, passive joint movement and pain), with a maximum total score of 60 points.
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Action Research Arm Test (ARAT)
Action Research Arm Test (ARAT) consists of 19 items grouped in subtests (i.e., grasp, grip, pinch, and gross arm movement) and performance of each item rated on a 4 points scale (from 0 - no movement possible, to 3 - movement performed normally.
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Instrumented Active Range of Motion (AROM) of affected Upper Limb
The instrumental assessment of the Active Range of Motion (AROM) of the upper limb includes shoulder flexion-extension/abduction and adduction, elbow flexion-extension, wrist flexion-extension/ulnar-radial deviation, and forearm pronation-supination. This will be performed using three inertial sensors located within the PABLO device (Tyromotion, AU)
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Instrumental gross and fine motor grip strength of hand affected
The instrumental assessment of the Gross and fine motor grip strength of hand affected includes grasping and releasing, pincer grip, three-finger grip, lateral grip and interdigital grip. This will be performed using Handesensor within the PABLO device (Tyromotion, AU)
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
National Institute of Health Stroke Scale Italian version (NIHSS-IT)
NIHSS-IT is a standardized ordinal scale determining stroke severity. The scale includes the following domains: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment item is scored ranging from 0 to 2, or 0 to 3 or 0 to 4, depending on the specific domain assessed. The total score results from the sum of all item scores and range from 0 to 42, where 0 indicates the absence of impairments, whereas 42 reflects the most severity stroke.
Time frame: Baseline (T0) at enrollment
Oxford Community Stroke Project (OCSP)
OCPS is a clinical classification used to predict the lesion site after stroke. The scale identifies 4 subgroups of cerebral infarction: 1. Total Anterior Cerebral Infarction (TACI): cortical and subcortical involvement; 2. Partial Anterior Cerebral Infarction (PACI): predominantly cortical involvement; 3. Posterior Circulation Infarcts (POCI): vertebrobasilar territory involvement; 4. Lacunar Infarcts (LACI): deep perforating arteries territory involvement.
Time frame: Baseline (T0) at enrollment
Modified Ashworth Scale (MAS)
It is a clinical scale to assess muscle tone during passive mobilization. The score ranges from 0 (no muscle tone increase) to 4 (spasticity). In this study it will be evaluated only for biceps brachii and flexor carpi.
Time frame: Baseline (T0) at enrollment
Montreal Cognitive Assessment (MoCA)
It is a screening tool used to assess the following cognitive domains: short-term memory, visuospatial abilities, executive functions, attention and concentration, language and orientation. Score ranges from 0 (severe cognitive impairment) to 30 points (normal cognitive function). MoCA is used as an inclusion criteria, with a cut-off score of 24, indicating no more than Mild Cognitive Impairment (MCI).
Time frame: Baseline (T0) at enrollment
Motricity Index (MI)
This outcome measure identifies and quantifies the strength of three UL movements: pinch grasp, elbow flexion and shoulder abduction. Each item is classified similarly to the Medical Research Council (MRC). The total scores range from 0 (no movement) to 100 (normal strenght);
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
Box and Block Test (BBT)
It is a clinical test that measures gross manual dexterity. The patient is asked to move in 60 seconds the highest possible number of wooden blocks from one side of a box to the other, over a central partition;
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
Barthel Index (BI)
It is a 10-item ordinal scale used to measure person's ability to complete Activity of Daily Living (ADL). The score varies from 0 (totally dependent) to 100 (completely independent). Items assess ability inferring, transfers (moving from wheelchair to bed and return), personal toilet, getting on and of toilet, bathing self, walking, ascend and descend stirs, dressing, controlling bowels and controlling bladder.
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
EuroQuol-5D (EQ-5D)
It is a subjective questionnaire used to assess the patient's perception of their quality of life in relation to their health status
Time frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
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Azienda Unita Sanitaria Locale di Piacenza