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PARKINSON DISEASE (Disorder)CROSS-NDNCT07384143

Cognitive Recovery Via Sensor-based Robotic Upper Limb Rehabilitation in Neurological Disorders

A study testing Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR) and Standard Conventional Therapy in people with PARKINSON DISEASE (Disorder) and Multiple Sclerosis, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR) and Standard Conventional Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteItaly
Study dates
11 Feb 2025to 11 Feb 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe cognitive disorders
  • Behavioral disorders
  • Sensory disorders

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Désirée Latella contact

+393458747117

desiree.latella@ircssme.it

Italy1 site, 1 recruiting

  • IRCCS Centro Neurolesi Bonino-Pulejo

    Messina, Maine, 98124

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read more

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

Read the 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.

Being tested
Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR), Standard Conventional Therapy
Medical subject headings
Parkinson Disease, Multiple Sclerosis, Stroke, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • Standard Conventional TherapyDevice

    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.

Study groups in NCT07384143
Study groupRoleWhat they receive
Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)ExperimentalParticipants 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.
Receives: Device: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)
Standard Conventional Therapy (SCT)Active comparatorParticipants receive conventional upper limb rehabilitation, including standard physiotherapy exercises, without robotic assistance or integrated cognitive tasks.
Receives: Device: Standard Conventional Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease)

    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.

    Measured: 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).

  2. Between-group difference in change from baseline in Brief Repeatable Neuropsychological Test (BRNT) composite score (Multiple Sclerosis)

    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.

    Measured: 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).

  3. Between-group difference in change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index score (Stroke)

    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.

    Measured: 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 outcomes (3)

  1. Between-group difference in change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE/FMA-UL) score

    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.

    Measured: 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).

  2. System Usability Scale (SUS) score for robotic device usability at end of treatment

    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]).

    Measured: 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).

  3. Goal Attainment Scaling (GAS) T-score at end of treatment

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start11 Feb 2025
  3. Primary completion11 Feb 2030 (estimated)
  4. Study completion11 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
189 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384143
Sponsor's protocol ID
CROSS-ND
Acronym
CROSS-ND
Status last verified
Feb 2025
First submitted
30 Sep 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bard-Pondarre R, Villepinte C, Roumenoff F, Lebrault H, Bonnyaud C, Pradeau C, Bensmail D, Isner-Horobeti ME, Krasny-Pacini A. Goal Attainment Scaling in rehabilitation: An educational review providing a comprehensive didactical tool box for implementing Goal Attainment Scaling. J Rehabil Med. 2023 Jun 14;55:jrm6498. doi: 10.2340/jrm.v55.6498.

    PubMed 37317629

  • Moulaei K, Moulaei R, Bahaadinbeigy K. The most used questionnaires for evaluating the usability of robots and smart wearables: A scoping review. Digit Health. 2024 Apr 9;10:20552076241237384. doi: 10.1177/20552076241237384. eCollection 2024 Jan-Dec.

    PubMed 38601185

  • Bull R, Espy KA, Senn TE. A comparison of performance on the Towers of London and Hanoi in young children. J Child Psychol Psychiatry. 2004 May;45(4):743-54. doi: 10.1111/j.1469-7610.2004.00268.x.

    PubMed 15056306

  • Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.

    PubMed 9845158

  • Solari A, Filippini G, Mendozzi L, Ghezzi A, Cifani S, Barbieri E, Baldini S, Salmaggi A, Mantia LL, Farinotti M, Caputo D, Mosconi P. Validation of Italian multiple sclerosis quality of life 54 questionnaire. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):158-62. doi: 10.1136/jnnp.67.2.158.

    PubMed 10406981

  • Tedone N, Vizzino C, Meani A, Gallo A, Altieri M, D'Ambrosio A, Pantano P, Piervincenzi C, Tommasin S, De Stefano N, Cortese R, Stromillo ML, Rocca MA; INNI network; Filippi M. The brief repeatable battery of neuropsychological tests (BRB-N) version a: update of Italian normative data from the Italian Neuroimaging Network Initiative (INNI). J Neurol. 2024 Apr;271(4):1813-1823. doi: 10.1007/s00415-023-12108-z. Epub 2023 Dec 7.

    PubMed 38060030

  • Galeoto G, Colalelli F, Massai P, Berardi A, Tofani M, Pierantozzi M, Servadio A, Fabbrini A, Fabbrini G. Quality of life in Parkinson's disease: Italian validation of the Parkinson's Disease Questionnaire (PDQ-39-IT). Neurol Sci. 2018 Nov;39(11):1903-1909. doi: 10.1007/s10072-018-3524-x. Epub 2018 Aug 7.

    PubMed 30088166

  • Nocentini U, Giordano A, Di Vincenzo S, Panella M, Pasqualetti P. The Symbol Digit Modalities Test - Oral version: Italian normative data. Funct Neurol. 2006 Apr-Jun;21(2):93-6.

    PubMed 16796824

  • Siciliano M, Chiorri C, Battini V, Sant'Elia V, Altieri M, Trojano L, Santangelo G. Regression-based normative data and equivalent scores for Trail Making Test (TMT): an updated Italian normative study. Neurol Sci. 2019 Mar;40(3):469-477. doi: 10.1007/s10072-018-3673-y. Epub 2018 Dec 7.

    PubMed 30535956

  • Siciliano M, Raimo S, Tufano D, Basile G, Grossi D, Santangelo F, Trojano L, Santangelo G. The Addenbrooke's Cognitive Examination Revised (ACE-R) and its sub-scores: normative values in an Italian population sample. Neurol Sci. 2016 Mar;37(3):385-92. doi: 10.1007/s10072-015-2410-z. Epub 2015 Nov 12.

    PubMed 26563847

  • Hoonhorst MH, Nijland RH, van den Berg JS, Emmelot CH, Kollen BJ, Kwakkel G. How Do Fugl-Meyer Arm Motor Scores Relate to Dexterity According to the Action Research Arm Test at 6 Months Poststroke? Arch Phys Med Rehabil. 2015 Oct;96(10):1845-9. doi: 10.1016/j.apmr.2015.06.009. Epub 2015 Jul 2.

    PubMed 26143054

  • Li, X., Tang, Z., Wu, D., Su, L., Zheng, Y., Chen, P., Zhang, Y., Dou, Z., Li, K., & Hoseinbeyki, A. (2021). Analysis of the Positive Effect of Robot-Assisted Virtual Reality Technology on Rehabilitation of Motor Function and Nerve Function in Cerebral Stroke Patients. J. Medical Imaging Health Informatics, 11, 595-600. https://doi.org/10.1166/jmihi.2021.3372.

  • Manuli A, Maggio MG, Latella D, Cannavo A, Balletta T, De Luca R, Naro A, Calabro RS. Can robotic gait rehabilitation plus Virtual Reality affect cognitive and behavioural outcomes in patients with chronic stroke? A randomized controlled trial involving three different protocols. J Stroke Cerebrovasc Dis. 2020 Aug;29(8):104994. doi: 10.1016/j.jstrokecerebrovasdis.2020.104994. Epub 2020 Jun 13.

    PubMed 32689601

  • Metzger JC, Lambercy O, Califfi A, Conti FM, Gassert R. Neurocognitive robot-assisted therapy of hand function. IEEE Trans Haptics. 2014 Apr-Jun;7(2):140-9. doi: 10.1109/TOH.2013.72.

    PubMed 24968378

  • Calabro RS, Naro A, Russo M, Bramanti P, Carioti L, Balletta T, Buda A, Manuli A, Filoni S, Bramanti A. Shaping neuroplasticity by using powered exoskeletons in patients with stroke: a randomized clinical trial. J Neuroeng Rehabil. 2018 Apr 25;15(1):35. doi: 10.1186/s12984-018-0377-8.

    PubMed 29695280

Questions about this trial

What is this clinical trial studying?

A study testing Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR) and Standard Conventional Therapy in people with PARKINSON DISEASE (Disorder) and Multiple Sclerosis, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Désirée Latella (+393458747117, desiree.latella@ircssme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07384143, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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