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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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 bot
• Устройство 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.

Первичные конечные точки

• Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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).]

Вторичные конечные точки (3)

• Between-group difference in change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE/FMA-UL) score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Severe cognitive disorders
• Behavioral disorders
• Sensory disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Centro Neurolesi Bonino-Pulejo — Messina

Публикации

• 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. PMID 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. PMID 38601185
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• 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. PMID 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. PMID 10406981
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• 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. PMID 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. PMID 16796824

Идентификаторы

NCT: NCT07384143 · CROSS-ND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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