Cognitive Recovery Via Sensor-based Robotic Upper Limb Rehabilitation
Exploring Cognitive Recovery: the Impact of Sensor-based Robotic Rehabilitation in Neurological and Neurodegenerative Disorders
What it found
No result yet.
What was tested
Treatment tested
- Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)
Compared with
- Standard Conventional Therapy
What it measured
Main measures
Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease)
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).
MRI lesionsThinking and memoryBetween-group difference in change from baseline in Brief Repeatable Neuropsychological Test (BRNT) composite score (Multiple Sclerosis)
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).
MRI lesionsThinking and memoryBetween-group difference in change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index score (Stroke)
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).
MRI lesionsThinking and memory
Other measures (3)
Between-group difference in change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE/FMA-UL) score
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).
MRI lesionsArm and hand functionSystem Usability Scale (SUS) score for robotic device usability at end of treatment
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).
MRI lesionsGoal Attainment Scaling (GAS) T-score at end of treatment
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).
MRI lesions
Who could take part
MS (type not specified) · 18 to 75
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
Papers
Background
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.Background
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.Background
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.Background
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.Background
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.Background
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-Background
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.Background
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.Background
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.Background
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.
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History
Started
Feb 2025
Main results due
Feb 2030
Finished
Feb 2030