Amyotrophic Lateral Sclerosis, Mild Cognitive Impairment (MCI), PARKINSON DISEASE (Disorder), Stroke
Conditions
Keywords
Collaborative Robot, Robotic rehabilitation, Neurological disorders, Graphical User Interface
Brief 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 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.
Interventions
DEVICEAuto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation
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.
OTHERconventional therapy
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.
Sponsors
University of Pavia
Istituti Clinici Scientifici Maugeri SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) score | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score | Baseline and end of treatment (after 12 sessions) | 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. |
| Fugl-Meyer Assessment Score | Baseline and end of treatment (after 12 sessions) | 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. |
| ABILHAND Scale Score | Baseline and end of treatment (after 12 sessions) | 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. |
| Action Research Arm Test (ARAT) Score | Baseline and end of treatment (after 12 sessions) | 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. |
| Modified Ashworth Scale (MAS) Score | Baseline and end of treatment (after 12 sessions) | 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. |
| Bradykinesia Scale Score | Baseline and end of treatment (after 12 sessions) | 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. |
| EuroQol-5D (EQ-5D) Score | Baseline and end of treatment (after 12 sessions) | 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. |
| Psychosocial Impact of Assistive Devices Scale (PIADS) Score | End of treatment (after 12 sessions) | 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. |
| Trail Making Test A score | Baseline and end of treatment (after 12 sessions) | 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. |
| Stroop Test score | Baseline and end of the treatment (after 12 sessions) | 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. |
| Digit Span Test score | Baseline and end of the treatment (after 12 sessions). | 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. |
| Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score | Baseline and End of the Treatment (after 12 sessions). | 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. |
Contacts
CONTACTCira Fundarò, MD
STUDY_DIRECTORAntonella Ferrara, PhD
University of Pavia
PRINCIPAL_INVESTIGATORCira Fundarò, MD
Istituti Clinici Scientifici Maugeri SpA
Outcome results
None listed