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

N/ANot Yet RecruitingNCT07636538

University of Pavia30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At the end of the treatment (after 12 sessions).

Secondary Outcomes

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.