StrokeNEURO-TECHNCT07698405
Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke
An observational study of Stroke, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Technology-based UL rehabilitation
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fiorenzuola d'Arda Hospital - AUSL Piacenza
Fiorenzuola d'Arda, Piacenza, 29017
Gianfranco Lamberti, MD, +39 0523 404656, g.lamberti2@ausl.pc.it
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Technology-based UL rehabilitation
- Keywords
- Stroke, Technology-Assisted Rehabilitation, Robotics, Virtual Reality, Motor Recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based UL rehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PwS | Adult People with Stroke (PwS) with Upper Limb (UL) motor function impairment Receives: Device: Technology-based UL rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Secondary outcomes (2)
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)
Measured: 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)
Measured: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Lamberti, MD, Azienda Unita Sanitaria Locale di Piacenza
- Investigators
- Gianfranco Lamberti, MD, Principal investigator, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698405
- Sponsor's protocol ID
- NEURO-TECH
- Acronym
- NEURO-TECH
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.
PubMed 21474804Yoo SD, Lee HH. The Effect of Robot-Assisted Training on Arm Function, Walking, Balance, and Activities of Daily Living After Stroke: A Systematic Review and Meta-Analysis. Brain Neurorehabil. 2023 Sep 20;16(3):e24. doi: 10.12786/bn.2023.16.e24. eCollection 2023 Nov.
PubMed 38047093O'Flaherty D, Ali K. Recommendations for Upper Limb Motor Recovery: An Overview of the UK and European Rehabilitation after Stroke Guidelines (2023). Healthcare (Basel). 2024 Jul 18;12(14):1433. doi: 10.3390/healthcare12141433.
PubMed 39057576Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. doi: 10.1136/jnnp.53.7.576.
PubMed 2391521Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
PubMed 17876068Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Mehrholz J, Pollock A, Pohl M, Kugler J, Elsner B. Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke. J Neuroeng Rehabil. 2020 Jun 30;17(1):83. doi: 10.1186/s12984-020-00715-0.
PubMed 32605587MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
PubMed 3160243McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
PubMed 18833688Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upper-extremity measures early after stroke. Arch Phys Med Rehabil. 2008 Sep;89(9):1693-700. doi: 10.1016/j.apmr.2008.02.022.
PubMed 18760153Arya KN, Verma R, Garg RK. Estimating the minimal clinically important difference of an upper extremity recovery measure in subacute stroke patients. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:599-610. doi: 10.1310/tsr18s01-599.
PubMed 22120029Cicerone Consensus Conference. Linee di indirizzo per l'utilizzo delle tecnologie riabilitative. Consensus Conference CICERONE 2022
Loureiro RC, Harwin WS, Nagai K, Johnson M. Advances in upper limb stroke rehabilitation: a technology push. Med Biol Eng Comput. 2011 Oct;49(10):1103-18. doi: 10.1007/s11517-011-0797-0. Epub 2011 Jul 20.
PubMed 21773806
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke
- ClinicalTrials.gov ID
- NCT07698405
- Acronym / sponsor ID
- NEURO-TECH / NEURO-TECH
- Conditions
- Stroke
- Keywords
- Stroke, Technology-Assisted Rehabilitation, Robotics, Virtual Reality, Motor Recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PwS | – | Device: Technology-based UL rehabilitationAdult People with Stroke (PwS) with Upper Limb (UL) motor function impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-based UL rehabilitationParticipants 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. | Device | PwS |
Primary outcome
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.
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.
2 secondary outcomes
Instrumented Active Range of Motion (AROM) of affected Upper Limb
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 21474804Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.
- Background: PubMed 38047093Yoo SD, Lee HH. The Effect of Robot-Assisted Training on Arm Function, Walking, Balance, and Activities of Daily Living After Stroke: A Systematic Review and Meta-Analysis. Brain Neurorehabil. 2023 Sep 20;16(3):e24. doi: 10.12786/bn.2023.16.e24. eCollection 2023 Nov.
- Background: PubMed 39057576O'Flaherty D, Ali K. Recommendations for Upper Limb Motor Recovery: An Overview of the UK and European Rehabilitation after Stroke Guidelines (2023). Healthcare (Basel). 2024 Jul 18;12(14):1433. doi: 10.3390/healthcare12141433.
- Background: PubMed 2391521Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. doi: 10.1136/jnnp.53.7.576.
- Background: PubMed 17876068Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Background: PubMed 32605587Mehrholz J, Pollock A, Pohl M, Kugler J, Elsner B. Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke. J Neuroeng Rehabil. 2020 Jun 30;17(1):83. doi: 10.1186/s12984-020-00715-0.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Background: PubMed 3160243Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
- Background: PubMed 18833688McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 18760153Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upper-extremity measures early after stroke. Arch Phys Med Rehabil. 2008 Sep;89(9):1693-700. doi: 10.1016/j.apmr.2008.02.022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianfranco Lamberti, MD principal investigator
Azienda Unita Sanitaria Locale di Piacenza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Lamberti, MD (+39 0523 404656, g.lamberti2@ausl.pc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698405, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.