Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (ASULDAR)

활성 비교기: Conventional Therapy

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).

다른: conventional 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.

실험적: Robotic Therapy

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.

장치: Auto-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.

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.

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.

Incidence of Adverse Events

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.