Cognitive Recovery Via Sensor-based Robotic Upper Limb Rehabilitation in Neurological Disorders (CROSS-ND)

IRCCS Centro Neurolesi Bonino Pulejo

Status: Enrolling

Conditions: Stroke; Multiple Sclerosis; Neurological Disorders; PARKINSON DISEASE (Disorder)

Treatments: Device: Standard Conventional Therapy; Device: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)

Study type: Interventional

Funder types: Other

Identifiers

NCT07384143

CROSS-ND

Details and patient eligibility

About

The goal of this clinical trial is to learn if sensor-based robotic upper limb rehabilitation can improve cognitive and motor functions in adults with neurological and neurodegenerative disorders, including Parkinson's disease, multiple sclerosis, and stroke. The main questions it aims to answer are:

Does sensor-based robotic rehabilitation improve cognitive functions such as attention, memory, and executive functions? Does this rehabilitation lead to better motor recovery and daily functioning compared to conventional therapy? Researchers will compare the experimental group receiving robotic rehabilitation with cognitive tasks to the control group receiving conventional therapy to see if the robotic approach leads to greater improvements in both cognitive and motor outcomes.

Participants will:

Receive upper limb rehabilitation using robotic devices and virtual reality-based exercises or conventional therapy Complete a series of neuropsychological assessments before and after the intervention to measure cognitive changes Complete motor function tests before and after the intervention to evaluate physical improvements Participate in 25 training sessions, 2-3 times per week, each lasting 60 minutes

Full description

The CROSS-ND study is a randomized controlled trial designed to evaluate the effectiveness of sensor-based robotic upper limb rehabilitation combined with cognitive exercises in adults with neurological and neurodegenerative disorders, including Parkinson's disease, multiple sclerosis, and stroke. Traditional rehabilitation often focuses primarily on motor recovery, but cognitive impairments frequently co-occur and can limit functional gains. This study integrates cognitive tasks within robotic rehabilitation to target both motor and cognitive deficits simultaneously, promoting neuroplasticity and functional independence.

Participants will be randomly assigned to either the experimental group, receiving robotic and virtual reality-based upper limb training with embedded cognitive exercises, or the control group, receiving conventional therapy. Each participant will complete 25 sessions over 2-3 months, with training intensity and difficulty adapted to individual performance.

Assessments will include neuropsychological tests tailored to the patient's condition (ACE-R for Parkinson's, BRB-N for multiple sclerosis, RBANS for stroke) and motor evaluations using standardized tools such as Fugl-Meyer Assessment, Nine Hole Peg Test, and robotic device metrics. Cognitive and motor outcomes will be measured at baseline (T0) and immediately post-intervention (T1).

This study aims to demonstrate that a personalized, integrated rehabilitation approach can improve cognitive functions (attention, memory, executive functions, visuospatial skills) while enhancing motor recovery and daily living activities. Secondary objectives include analyzing correlations between cognitive and motor improvements, evaluating psychological well-being, and exploring the influence of patient characteristics (age, severity, disease stage) on rehabilitation outcomes.

Enrollment: 189 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 years;
• FMA-UL 0-31: eligible for exoskeletons and robotic devices with high support. (Armeo Power, Amadeo, Motore)
• FMA-UL 32-47: eligible for end-effectors with medium support. (Armeo Spring, Hand Tutor, Diego)
• FMA-UL 48-52: eligible for sensor-based with low support. (Pablo, Diego, Armeo Senso)
• MoCA: ≤ 20

Exclusion criteria

• Severe cognitive disorders
• Behavioral disorders
• Sensory disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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189 participants in 2 patient groups

Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)

Experimental group

Description:

Participants receive upper limb rehabilitation using sensor-based robotic devices and virtual reality exercises, with integrated cognitive tasks to simultaneously improve motor function and cognitive abilities.

Treatment:

Device: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)

Standard Conventional Therapy (SCT)

Active Comparator group

Description:

Participants receive conventional upper limb rehabilitation, including standard physiotherapy exercises, without robotic assistance or integrated cognitive tasks.

Treatment:

Device: Standard Conventional Therapy