Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke (NEURO-TECH)

July 7, 2026 updated by: Gianfranco Lamberti, MD, Azienda Unita Sanitaria Locale di Piacenza

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  • Intensive Visual Stimulation - IVS3 (Dessintey Co., France), a system for mirror therapy and motor imagery targeting motor planning and movement control;
  • Gloreha Professional 2 + Active Package (BTL Robotics, Italy), a soft robotic glove for hand rehabilitation;
  • PABLO® (Tyromotion, Austria), a multifunctional rehabilitation device based on sensors and interactive interfaces;
  • DIEGO® (Tyromotion, Austria), an end-effector device designed for assistive and interactive therapies.

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:

  • 10 points on the FMA-UE (10)
  • 12 points on the ARAT (11)

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Piacenza
      • Fiorenzuola d'Arda, Piacenza, Italy, 29017
        • Recruiting
        • Fiorenzuola d'Arda Hospital - AUSL Piacenza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • First-ever unilateral ischemic or hemorrhagic stroke;
  • Presence of upper limb motor impairment;
  • Modified Ashworth Scale (MAS) < 3;
  • Montreal Cognitive Assessment (MoCA) > 24;
  • Medically stable and able to participate in an intensive rehabilitation programme;
  • Ability to understand and follow study procedures;
  • Written informed consent.

Exclusion Criteria:

  • Diagnosis of severe aphasia, based on medical records, preventing participation;
  • Bilateral hemisphere lesions;
  • Severe and unstable medical conditions (e.g. untreated seizure, heart failure) that preclude participation in rehabilitation;
  • Other neurological and/or psychiatric diseases;
  • Recent and unstabilized upper limb fracture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PwS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
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.
Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Action Research Arm Test (ARAT)
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
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.
Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumented Active Range of Motion (AROM) of affected Upper Limb
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
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)
Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Instrumental gross and fine motor grip strength of hand affected
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
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)
Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institute of Health Stroke Scale Italian version (NIHSS-IT)
Time Frame: Baseline (T0) at enrollment
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.
Baseline (T0) at enrollment
Oxford Community Stroke Project (OCSP)
Time Frame: Baseline (T0) at enrollment

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.
Baseline (T0) at enrollment
Modified Ashworth Scale (MAS)
Time Frame: Baseline (T0) at enrollment
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.
Baseline (T0) at enrollment
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline (T0) at enrollment
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. It is used as an inclusion criteria, with a cut-off score of 24, which indicates Mild Cognitive Impairment (MCI).
Baseline (T0) at enrollment
Motricity Index (MI)
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
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);
Baseline (T0) at enrollment, and after 4-5 weeks (T1)
Box and Block Test (BBT)
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
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;
Baseline (T0) at enrollment, and after 4-5 weeks (T1)
Barthel Index (BI)
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
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.
Baseline (T0) at enrollment, and after 4-5 weeks (T1)
EuroQuol-5D (EQ-5D)
Time Frame: Baseline (T0) at enrollment, and after 4-5 weeks (T1)
It is a subjective questionnaire used to assess the patient's perception of their quality of life in relation to their health status
Baseline (T0) at enrollment, and after 4-5 weeks (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unita Sanitaria Locale di Piacenza

Investigators

  • Principal Investigator: Gianfranco Lamberti, MD, Azienda Unita Sanitaria Locale di Piacenza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEURO-TECH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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