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

January 26, 2026 updated by: Desiree La Tella, IRCCS Centro Neurolesi Bonino Pulejo

Exploring Cognitive Recovery: the Impact of Sensor-based Robotic Rehabilitation in Neurological and Neurodegenerative Disorders

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Maine
      • Messina, Maine, Italy, 98124
        • Recruiting
        • IRCCS Centro Neurolesi Bonino-Pulejo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)
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.
Device: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)
Participants receive upper limb rehabilitation using sensor-based robotic devices (e.g., Motore, Armeo Senso, Hand Tutor, Armeo Power, Armeo Spring, Pablo, Amadeo, Diego) combined with virtual reality exercises. The intervention integrates cognitive tasks-such as attention, memory, and executive function exercises-simultaneously with motor training. Therapy is personalized in real-time according to each patient's performance, adjusting difficulty, intensity, and assistance levels to maximize both cognitive and motor recovery.
Active Comparator: Standard Conventional Therapy (SCT)
Participants receive conventional upper limb rehabilitation, including standard physiotherapy exercises, without robotic assistance or integrated cognitive tasks.
Device: Standard Conventional Therapy
Participants receive traditional upper limb rehabilitation, including standard physiotherapy exercises without robotic assistance or integrated cognitive tasks. Therapy focuses on motor recovery using conventional methods, such as repetitive movement exercises, range of motion, and functional tasks, but does not adapt in real-time to patient performance and does not include concurrent cognitive stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease)
Time Frame: From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
Addenbrooke's Cognitive Examination-Revised (ACE-R) total score ranges from 0 to 100, with higher scores indicating better cognitive performance. ACE-R will be administered at baseline (T0) and at end of intervention (T1). The primary metric will be change from baseline (T1 - T0) in ACE-R total score. Results will be summarized as mean (SD) change (or median [IQR] if non-normal) and compared between robotic rehabilitation and conventional therapy groups.
From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
Between-group difference in change from baseline in Brief Repeatable Neuropsychological Test (BRNT) composite score (Multiple Sclerosis)
Time Frame: From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
The BRB-N is a neuropsychological battery (multiple subtests). Subtest scores will be standardized into z-scores and aggregated into a composite (e.g., mean z-score across predefined subtests). Z-scores have no fixed minimum or maximum; higher values indicate better cognitive performance.The BRNT will be administered at T0 and T1. The primary metric will be change from baseline (T1 - T0) in a composite score derived from BRNT components (standardized z-scores aggregated into a single composite). Results will be summarized as mean (SD) change and compared between groups.
From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
Between-group difference in change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index score (Stroke)
Time Frame: From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
RBANS Total Scale Index score ranges from 40 to 160, with higher scores indicating better cognitive performance. RBANS will be administered at T0 and T1. The primary metric will be change from baseline (T1 - T0) in RBANS Total Scale Index score. Results will be summarized as mean (SD) change (or median [IQR]) and compared between robotic rehabilitation and conventional therapy groups.
From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group difference in change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE/FMA-UL) score
Time Frame: From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).
FMA-UE score ranges from 0 to 66, with higher scores indicating better upper-limb motor function. FMA-UL will be assessed at T0 and T1. Metric: change from baseline (T1 - T0). Summaries: mean (SD) change and between-group comparison.
From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).
System Usability Scale (SUS) score for robotic device usability at end of treatment
Time Frame: From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).
SUS total score ranges from 0 to 100, with higher scores indicating better usability. Participants will complete the SUS at T1 to evaluate usability of the robotic device. Metric: SUS total score. Summaries: mean (SD) (or median [IQR]).
From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).
Goal Attainment Scaling (GAS) T-score at end of treatment
Time Frame: From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).
GAS is calculated as a standardized T-score typically centered at 50 (SD 10); scores >50 indicate better-than-expected goal attainment, while scores <50 indicate less-than-expected attainment. Individualized rehabilitation goals will be defined at baseline and evaluated at T1 using GAS. Metric: GAS T-score at T1 (or change, se lo calcoli). Summaries: mean (SD) and between-group comparison.
From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2025

Primary Completion (Estimated)

February 11, 2030

Study Completion (Estimated)

February 11, 2030

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROSS-ND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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