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| Name | Class |
|---|---|
| Istituti Clinici Scientifici Maugeri SpA | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cira Fundarò, MD | Contact | +393348941743 | cira.fundaro@icsmaugeri.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonella Ferrara, PhD | University of Pavia | Study Director |
| Cira Fundarò, MD | Istituti Clinici Scientifici Maugeri SpA | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2024 |
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|
| conventional therapy | Other | 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. |
|
| 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. | At the end of the treatment (after 12 sessions). |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and End of the Treatment (after 12 sessions). |
| May 23, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2023 | May 23, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000690 | Amyotrophic Lateral Sclerosis |
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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