StrokeASULDARNCT07636538
Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation
A study testing Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation and conventional therapy in people with Stroke and Amyotrophic Lateral Sclerosis, run by University of Pavia.
Trial summary
This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Amyotrophic Lateral Sclerosis, PARKINSON DISEASE (Disorder)
- What is being tested?
- Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged between 18 and 80 years.
- Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).
- Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.
- Ability to understand and follow the study protocol instructions.
Who cannot join
- Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.
- Individuals unable to provide informed consent.
- Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.
- Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).
- Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.
- Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)
This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).
The system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.
Read more
The main questions the study aims to answer are:
Is the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?
Researchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.
Thirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.
Participants will undergo:
Baseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.
- Conditions
- Stroke, Amyotrophic Lateral Sclerosis, PARKINSON DISEASE (Disorder), Mild Cognitive Impairment (MCI)
- Being tested
- Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation, conventional therapy
- Keywords
- Collaborative Robot, Robotic rehabilitation, Neurological disorders, Graphical User Interface
- Medical subject headings
- Stroke, Amyotrophic Lateral Sclerosis, Parkinson Disease, Cognitive Dysfunction, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational RehabilitationDevice
Participants will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. The investigational robotic system provides adaptive upper limb rehabilitation exercises tailored to the patient's motor performance. Training includes task-oriented reaching exercises combined with cognitive tasks requiring target sequence memorization, as well as trajectory-tracking exercises in which the robot guides the patient's hand along predefined movements recorded by the therapist. Exercise difficulty is progressively adjusted according to patient performance during previous sessions.
conventional therapyOther
Participants will receive conventional rehabilitation therapy according to standard clinical practice for upper limb motor rehabilitation. Treatment sessions will last 60 minutes, three times per week, for a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | Ten patients with similar upper limb functional impairment (Parkinson's Disease, Amyotrophic Lateral Sclerosis, and post-stroke sequelae) and five patients with or without upper limb functional impairment but affected by early cognitive impairment (Mild Cognitive Impairment, MCI) will undergo conventional rehabilitation therapy only. In particular, they will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week). Receives: Other: conventional therapy |
| Robotic Therapy | Experimental | Ten patients with upper limb motor functional impairment, as assessed by the QuickDASH scale with scores ranging from 20 to 90, due to chronic neurological diseases (Parkinson's Disease and Amyotrophic Lateral Sclerosis) or post-acute conditions (post-stroke sequelae), and five patients with or without upper limb motor functional impairment but affected by early cognitive impairment (Mild Cognitive Impairment, MCI), will receive treatment sessions using the investigational device in addition to conventional rehabilitation therapy sessions. In particular, they will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. Exercise difficulty will be adapted according to the participant's performance. Receives: Device: Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS) score
Usability of the investigational device will be assessed using the System Usability Scale (SUS).
Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater perceived usability and therefore a better outcome.
Measured: at the end of treatment (after 12 sessions)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) Score
Participant satisfaction and usability assessment using the QUEST 2.0 questionnaire.
Minimum Value: 1 Maximum Value: 5 Interpretation: Higher scores indicate greater user satisfaction with the assistive technology and therefore a better outcome.
Measured: At the end of treatment (after 12 sessions)
Incidence of Adverse Events
Safety assessment based on the frequency of adverse events reported by participants or observed by operators during device use.
Measured: Throughout the study period (up to 12 sessions)
State Trait Anxiety Inventory (STAI) score
Anxiety associated with device use assessed through self-reported scale, State Trait Anxiety Inventory (STAI).
Scale Title: State-Trait Anxiety Inventory (STAI). Minimum Value: 20. Maximum Value: 80. Interpretation: Higher scores indicate greater anxiety and therefore a worse outcome.
Measured: Baseline and end of treatment
Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) Usability Questionnaire Score
Usability assessment evaluating the ability of users to safely, effectively, and efficiently interact with the system.
Scale Title: Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) - Usability Domain.
Minimum Value: 5. Maximum Value: 20. Interpretation: Higher scores indicate better perceived usability of the technology-assisted rehabilitation device and therefore a better outcome.
Measured: At the end of treatment (after 12 sessions)
Perceived Stress Scale (PSS) score
Perceived stress due to the use of the device assessed via Perceived Stress Scale (PSS) score.
Scale Title: Perceived Stress Scale (PSS). Minimum Value: 0. Maximum Value: 40. Interpretation: Higher scores indicate greater perceived stress and therefore a worse outcome.
Measured: At the end of the treatment (after 12 sessions).
Secondary outcomes (12)
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Assessment of upper limb disability and motor function using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Scale Title: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater disability and symptoms of the upper extremity and therefore a worse outcome.
Measured: Baseline and end of treatment (after 12 sessions)
Fugl-Meyer Assessment Score
Evaluation of upper limb motor performance using the Fugl-Meyer Assessment. Minimum Value: 0. Maximum Value: 226. Interpretation: Higher scores indicate better sensorimotor function and therefore a better outcome.
Measured: Baseline and end of treatment (after 12 sessions)
ABILHAND Scale Score
Assessment of manual ability in activities of daily living using the ABILHAND scale.
Minimum Value: 0 . Maximum Value: Not strictly bounded. Interpretation: Higher scores indicate better perceived manual ability in performing daily activities and therefore a better outcome.
Measured: Baseline and end of treatment (after 12 sessions)
Action Research Arm Test (ARAT) Score
Evaluation of upper limb motor function using the Action Research Arm Test. Scale Title: Action Research Arm Test (ARAT) Minimum Value: 0. Maximum Value: 57. Interpretation: Higher scores indicate better upper limb function and dexterity and therefore a better outcome.
Measured: Baseline and end of treatment (after 12 sessions)
Modified Ashworth Scale (MAS) Score
Assessment of muscle spasticity using the Modified Ashworth Scale. Scale Title: Modified Ashworth Scale (MAS) Minimum Value: 0. Maximum Value: 4. Interpretation: Higher scores indicate increased muscle tone/spasticity and therefore a worse outcome.
Measured: Baseline and end of treatment (after 12 sessions)
Bradykinesia Scale Score
Motor performance assessment using the Bradykinesia Scale for Parkinson's disease.
Scale Title: Bradykinesia Scale (specify instrument/version used, e.g., UPDRS-III bradykinesia items or a dedicated bradykinesia rating scale).
Minimum Value: 0. Maximum Value: 132. Interpretation: Higher scores indicate greater bradykinesia (slower and more impaired voluntary movement) and therefore a worse outcome.
Measured: Baseline and end of treatment (after 12 sessions)
EuroQol-5D (EQ-5D) Score
Assessment of perceived quality of life using the EuroQol-5D questionnaire. Scale Title: EuroQol 5-Dimension Questionnaire (EQ-5D) Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate better health-related quality of life and therefore a better outcome.
Measured: Baseline and end of treatment (after 12 sessions)
Psychosocial Impact of Assistive Devices Scale (PIADS) Score
Evaluation of the psychosocial impact of the assistive device on participants' daily life via PIADS score.
Scale Title: Psychosocial Impact of Assistive Devices Scale (PIADS) Minimum Value: -3. Maximum Value: +3. Interpretation: Higher scores indicate a more positive psychosocial impact of the assistive device and therefore a better outcome.
Measured: End of treatment (after 12 sessions)
Trail Making Test A score
Cognitive performance assessment using the Trail Making Test A. Scale Title: Trail Making Test Part A (TMT-A) Minimum Value: 0 seconds. Maximum Value: No fixed maximum (time to completion in seconds; can be unbounded) Interpretation: Higher scores (longer completion time) indicate worse performance and therefore a worse outcome.
Measured: Baseline and end of treatment (after 12 sessions)
Stroop Test score
Brain's processing speed, attention control, and cognitive flexibility assessed via Stroop Test score.
Scale Title: Stroop Color and Word Test (Stroop Test) Minimum Value: 0. Maximum Value: No fixed maximum (time in seconds; unbounded) Interpretation: Higher scores indicate worse performance, therefore a worse outcome.
Measured: Baseline and end of the treatment (after 12 sessions)
Digit Span Test score
Short-term memory, attention, and working memory capacity assessed via Digit Span score.
Scale Title: Digit Span Test Minimum Value: 0 (no correct spans recalled). Maximum Value: 18 total items correct. Interpretation: Higher scores indicate better attention and working memory performance and therefore a better outcome.
Measured: Baseline and end of the treatment (after 12 sessions).
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score
Motor performance assessment using Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) for Amyotrophic Lateral Sclerosis.
Scale Title: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) Minimum Value: 0. Maximum Value: 48. Interpretation: Higher scores indicate better functional status and therefore a better outcome.
Measured: Baseline and End of the Treatment (after 12 sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Sponsor
- Investigators
- Antonella Ferrara, PhD, Study director, University of PaviaCira Fundarò, MD, Principal investigator, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636538
- Sponsor's protocol ID
- ASULDAR
- Acronym
- ASULDAR
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)
- ClinicalTrials.gov ID
- NCT07636538
- Acronym / sponsor ID
- ASULDAR / ASULDAR
- Conditions
- Stroke, Amyotrophic Lateral Sclerosis, PARKINSON DISEASE (Disorder), Mild Cognitive Impairment (MCI)
- Keywords
- Collaborative Robot, Robotic rehabilitation, Neurological disorders, Graphical User Interface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Jun 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 interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).
The system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.
The main questions the study aims to answer are:
Is the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?
Researchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.
Thirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.
Participants will undergo:
Baseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Other: conventional therapyTen patients with similar upper limb functional impairment (Parkinson's Disease, Amyotrophic Lateral Sclerosis, and post-stroke sequelae) and five patients with or without upper limb functional impairment but affected by early cognitive impairment (Mild Cognitive Impairment, MCI) will undergo conventional rehabilitation therapy only. In particular, they will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week). |
| Robotic Therapy | Experimental | Device: Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational RehabilitationTen patients with upper limb motor functional impairment, as assessed by the QuickDASH scale with scores ranging from 20 to 90, due to chronic neurological diseases (Parkinson's Disease and Amyotrophic Lateral Sclerosis) or post-acute conditions (post-stroke sequelae), and five patients with or without upper limb motor functional impairment but affected by early cognitive impairment (Mild Cognitive Impairment, MCI), will receive treatment sessions using the investigational device in addition to conventional rehabilitation therapy sessions. In particular, they will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. Exercise difficulty will be adapted according to the participant's performance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged between 18 and 80 years.
- Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).
- Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.
- Ability to understand and follow the study protocol instructions.
Key exclusion criteria (6 listed)
- Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.
- Individuals unable to provide informed consent.
- Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.
- Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).
- Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.
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 |
|---|---|---|
| Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational RehabilitationParticipants will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. The investigational robotic system provides adaptive upper limb rehabilitation exercises tailored to the patient's motor performance. Training includes task-oriented reaching exercises combined with cognitive tasks requiring target sequence memorization, as well as trajectory-tracking exercises in which the robot guides the patient's hand along predefined movements recorded by the therapist. Exercise difficulty is progressively adjusted according to patient performance during previous sessions. | Device | Robotic Therapy |
| conventional therapyParticipants will receive conventional rehabilitation therapy according to standard clinical practice for upper limb motor rehabilitation. Treatment sessions will last 60 minutes, three times per week, for a total of 12 sessions. | Other | Conventional Therapy |
Primary outcome
System Usability Scale (SUS) score
Time frame: at the end of treatment (after 12 sessions)
Usability of the investigational device will be assessed using the System Usability Scale (SUS). Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater perceived usability and therefore a better outcome.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) Score
Time frame: At the end of treatment (after 12 sessions)
Participant satisfaction and usability assessment using the QUEST 2.0 questionnaire. Minimum Value: 1 Maximum Value: 5 Interpretation: Higher scores indicate greater user satisfaction with the assistive technology and therefore a better outcome.
Incidence of Adverse Events
Time frame: Throughout the study period (up to 12 sessions)
Safety assessment based on the frequency of adverse events reported by participants or observed by operators during device use.
State Trait Anxiety Inventory (STAI) score
Time frame: Baseline and end of treatment
Anxiety associated with device use assessed through self-reported scale, State Trait Anxiety Inventory (STAI). Scale Title: State-Trait Anxiety Inventory (STAI). Minimum Value: 20. Maximum Value: 80. Interpretation: Higher scores indicate greater anxiety and therefore a worse outcome.
Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) Usability Questionnaire Score
Time frame: At the end of treatment (after 12 sessions)
Usability assessment evaluating the ability of users to safely, effectively, and efficiently interact with the system. Scale Title: Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) - Usability Domain. Minimum Value: 5. Maximum Value: 20. Interpretation: Higher scores indicate better perceived usability of the technology-assisted rehabilitation device and therefore a better outcome.
Perceived Stress Scale (PSS) score
Time frame: At the end of the treatment (after 12 sessions).
Perceived stress due to the use of the device assessed via Perceived Stress Scale (PSS) score. Scale Title: Perceived Stress Scale (PSS). Minimum Value: 0. Maximum Value: 40. Interpretation: Higher scores indicate greater perceived stress and therefore a worse outcome.
12 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time frame: Baseline and end of treatment (after 12 sessions)
Fugl-Meyer Assessment Score
Time frame: Baseline and end of treatment (after 12 sessions)
ABILHAND Scale Score
Time frame: Baseline and end of treatment (after 12 sessions)
Action Research Arm Test (ARAT) Score
Time frame: Baseline and end of treatment (after 12 sessions)
Modified Ashworth Scale (MAS) Score
Time frame: Baseline and end of treatment (after 12 sessions)
Bradykinesia Scale Score
Time frame: Baseline and end of treatment (after 12 sessions)
EuroQol-5D (EQ-5D) Score
Time frame: Baseline and end of treatment (after 12 sessions)
Psychosocial Impact of Assistive Devices Scale (PIADS) Score
Time frame: End of treatment (after 12 sessions)
Trail Making Test A score
Time frame: Baseline and end of treatment (after 12 sessions)
Stroop Test score
Time frame: Baseline and end of the treatment (after 12 sessions)
Digit Span Test score
Time frame: Baseline and end of the treatment (after 12 sessions).
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score
Time frame: Baseline and End of the Treatment (after 12 sessions).
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Antonella Ferrara, PhD study director
University of Pavia
Cira Fundarò, MD principal investigator
Istituti Clinici Scientifici Maugeri SpA
Questions about this trial
What is this clinical trial studying?
A study testing Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation and conventional therapy in people with Stroke and Amyotrophic Lateral Sclerosis, run by University of Pavia.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Cira Fundarò, MD (+393348941743, cira.fundaro@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) score (time frame: at the end of treatment (after 12 sessions)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.