Upper Limb Rehabilitation in People With Parkinson's Disease:
NCT ID: NCT06906679
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-12-20
2026-12-20
Brief Summary
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A - Experimental Group (EG) - robotic treatment for upper limb rehabilitation. B - Control Group (CG) - conventional treatment for upper limb rehabilitation.
Secondary objectives include:
\- Evaluating the effectiveness of an end-effector robotic system in terms of improving upper limb coordination and functionality through the ARAT test and the UPDRS.
Identifying subgroups of participants who may benefit more from robotic therapy based on PD disease stage (Hoehn \& Yahr), age, and upper limb impairment.
Analyzing the effects of robotic rehabilitation on quality of life.
Assessing participants' compliance and satisfaction levels with the robotic system in terms of improving participation in upper limb rehabilitation.
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Detailed Description
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PD progresses slowly, and while current treatments manage motor symptoms effectively in the early stages, their efficacy diminishes in advanced stages, with non-motor symptoms becoming more evident. Alongside pharmacotherapy, early and regular physical rehabilitation has shown benefits, improving motor function, posture control, balance, and strength while potentially delaying disease progression. The success of PD treatment depends on treatment quality, timing, and frequency. Conventional rehabilitation includes exercise, strategy training, and patient education, focusing on enhancing upper limb coordination, fluidity, and dexterity. Although some therapies improve motor function and non-motor symptoms, limited evidence exists regarding their impact on hand dexterity.
Robotic devices, leveraging neuroplasticity and motor learning principles, have been integrated into rehabilitation to maximize sensory input and provide targeted, task-specific stimuli to the central nervous system. Advances in technology have made robotic treatments more accessible, complementing traditional physiotherapy, particularly in upper limb neurorehabilitation.
Robotic-assisted therapy (RAT) has shown efficacy in stroke rehabilitation, improving upper limb function, spasticity, and daily living activities. However, research on robotic rehabilitation for PD has primarily focused on lower limbs and gait training (RAGT), demonstrating positive effects on motor function and balance, despite limited sample sizes and follow-up studies.
Regarding upper limb rehabilitation in PD, evidence is scarce. Some studies using virtual reality systems, like Oculus Rift 2 with Leap Motion Controller (OR2-LMC), have shown improvements in strength, fine and gross dexterity, and movement speed, although discrepancies between qualitative and quantitative results were noted. Picelli et al. (2014) found that robotic-assisted upper limb training improved sensorimotor functions, but the placebo effect cannot be ruled out, emphasizing the need for larger, randomized controlled trials comparing RAT to conventional rehabilitation.
More recently, Raciti L. et al. (2022) highlighted the efficacy of the Armeo exoskeleton in enhancing hand function, dexterity, and cognitive abilities, suggesting a promising avenue for PD rehabilitation (32).
Given the limited evidence on robotic rehabilitation for upper limb motor disorders in PD, this study aims to evaluate the effectiveness of an end-effector robotic device designed to improve shoulder, elbow, and wrist movements, strength, and coordination in individuals with mild to moderate PD, compared to conventional rehabilitation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group (EG)
Participants assigned to Experimental Group (EG) will follow 20 sessions (3 times/week) of robotic-assisted treatment for upper limb rehabilitation using the Motore (Humanware S.r.l, Pisa, Italia ) robotic device in addition to the standard rehabilitation program.
Experimental Group
The EG will follow 20 sessions of robot-assisted therapy for the upper limb. Exercises will be performed using a handpiece to support the weight of the upper limb during therapy and to assist (or resist) movements according to the patient's needs. These modalities are presented to the patient through visual and motor feedback (force feedback).
The exercises will focus on rehabilitating upper limb performance, for example:
Elbow: flexion-extension; Shoulder: horizontal adduction/abduction, flexion-extension.
The software includes serious games for:
* Motor control (both movement control and force control);
* Coordination;
* Cognitive training;
* Simulation of daily activities. The exercises will be defined by specialized personnel based on the patient's characteristics. Each rehabilitation session lasts 45 minutes, including 5 minutes for device setup, 20 minutes for the right upper limb and 20 minutes for the left upper limb.
Control Group (CG)
Participants assigned to Control Group (CG) will follow 20 sessions (3 times/week) of conventional tratment for upper limb rehabilitation in addition to the standard rehabilitation program.
control group
The CG will last 20 sessions (3 days/week) of conventional rehabilitative treatment without the use of technological devices for the upper limb. Each session will last 45 minutes. The motor exercises will focus on upper limb rehabilitation and will be performed with a therapist who will personalize the treatment based on the patient's characteristics and needs. Specifically, the upper limb treatment will include exercises for mobility (shoulder, elbow, wrist, and hand), coordination, and manual dexterity.
Interventions
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Experimental Group
The EG will follow 20 sessions of robot-assisted therapy for the upper limb. Exercises will be performed using a handpiece to support the weight of the upper limb during therapy and to assist (or resist) movements according to the patient's needs. These modalities are presented to the patient through visual and motor feedback (force feedback).
The exercises will focus on rehabilitating upper limb performance, for example:
Elbow: flexion-extension; Shoulder: horizontal adduction/abduction, flexion-extension.
The software includes serious games for:
* Motor control (both movement control and force control);
* Coordination;
* Cognitive training;
* Simulation of daily activities. The exercises will be defined by specialized personnel based on the patient's characteristics. Each rehabilitation session lasts 45 minutes, including 5 minutes for device setup, 20 minutes for the right upper limb and 20 minutes for the left upper limb.
control group
The CG will last 20 sessions (3 days/week) of conventional rehabilitative treatment without the use of technological devices for the upper limb. Each session will last 45 minutes. The motor exercises will focus on upper limb rehabilitation and will be performed with a therapist who will personalize the treatment based on the patient's characteristics and needs. Specifically, the upper limb treatment will include exercises for mobility (shoulder, elbow, wrist, and hand), coordination, and manual dexterity.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria;
* Hoehn \& Yahr scale score between 2 and 3 in the "ON" phase;
* Montreal Cognitive Assessment (MoCA) screening test with a score ≥ 17.54;
* Stable pharmacological therapy for at least 4 weeks and throughout the treatment;
* Ability to understand and sign the informed consent for the study;
* Signed informed consent for the study;
* Ability to comply with the study procedures.
Exclusion Criteria
* Neurological disorders overlapping with Parkinson's disease, psychiatric complications, or personality disorders;
* Presence of osteoarticular and neuromuscular diseases that may impair upper limb mobility;
* Participants who have not signed the informed consent for the study.
30 Years
80 Years
ALL
No
Sponsors
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Ministry of Health, Italy
OTHER_GOV
IRCCS San Raffaele Roma
OTHER
Responsible Party
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Principal Investigators
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Prof. Marco Franceschini, MD
Role: STUDY_CHAIR
IRCCS San Raffaele Roma
Prof. Marco Franceschini, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Roma
Locations
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San Raffaele Cassino
Cassino, FR, Italy
IRCCS San Raffaele Roma
Rome, Lazio, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.
Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
Ponsen MM, Daffertshofer A, Wolters ECh, Beek PJ, Berendse HW. Impairment of complex upper limb motor function in de novo Parkinson's disease. Parkinsonism Relat Disord. 2008;14(3):199-204. doi: 10.1016/j.parkreldis.2007.07.019. Epub 2007 Oct 2.
Quinn L, Busse M, Dal Bello-Haas V. Management of upper extremity dysfunction in people with Parkinson disease and Huntington disease: facilitating outcomes across the disease lifespan. J Hand Ther. 2013 Apr-Jun;26(2):148-54; quiz 155. doi: 10.1016/j.jht.2012.11.001. Epub 2012 Dec 8.
FITTS PM. The information capacity of the human motor system in controlling the amplitude of movement. J Exp Psychol. 1954 Jun;47(6):381-91. No abstract available.
Sanes JN. Information processing deficits in Parkinson's disease during movement. Neuropsychologia. 1985;23(3):381-92. doi: 10.1016/0028-3932(85)90024-7.
Jankovic J, Aguilar LG. Current approaches to the treatment of Parkinson's disease. Neuropsychiatr Dis Treat. 2008 Aug;4(4):743-57. doi: 10.2147/ndt.s2006.
Peall KJ, Kuiper A, de Koning TJ, Tijssen MA. Non-motor symptoms in genetically defined dystonia: Homogenous groups require systematic assessment. Parkinsonism Relat Disord. 2015 Sep;21(9):1031-40. doi: 10.1016/j.parkreldis.2015.07.003. Epub 2015 Jul 17.
Grazina R, Massano J. Physical exercise and Parkinson's disease: influence on symptoms, disease course and prevention. Rev Neurosci. 2013;24(2):139-52. doi: 10.1515/revneuro-2012-0087.
Capecci M, Pournajaf S, Galafate D, Sale P, Le Pera D, Goffredo M, De Pandis MF, Andrenelli E, Pennacchioni M, Ceravolo MG, Franceschini M. Clinical effects of robot-assisted gait training and treadmill training for Parkinson's disease. A randomized controlled trial. Ann Phys Rehabil Med. 2019 Sep;62(5):303-312. doi: 10.1016/j.rehab.2019.06.016. Epub 2019 Aug 1.
Keus SHJ, Munneke M, Graziano M, et al. European Physiotherapy Guideline for Parkinson's disease. s.l. : KNGF/ParkinsonNet, 2014.
Vercruysse S, Gilat M, Shine JM, Heremans E, Lewis S, Nieuwboer A. Freezing beyond gait in Parkinson's disease: a review of current neurobehavioral evidence. Neurosci Biobehav Rev. 2014 Jun;43:213-27. doi: 10.1016/j.neubiorev.2014.04.010. Epub 2014 Apr 23.
Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.
Other Identifiers
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RP 12/23
Identifier Type: -
Identifier Source: org_study_id
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