Parkinson DiseaseMOTORPARKNCT06906679
Upper Limb Rehabilitation in People With Parkinson's Disease:
A study testing Experimental Group in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial summary
This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Experimental Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Dec 2023to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 80 years;
- 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.
Who cannot join
- Unable to adhere to the exercise program due to poor compliance;
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Raffaele Cassino
Cassino, FR, 03043
IRCCS San Raffaele Roma
Rome, Lazio, 00163
About this study
Official title: Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study
This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional rehabilitation treatment. The study protocol will involve individuals diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank criteria, who will be randomly assigned to one of the following groups:
A - Experimental Group (EG) - robotic treatment for upper limb rehabilitation. B - Control Group (CG) - conventional treatment for upper limb rehabilitation.
Read more
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.
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting over 6 million individuals worldwide, with its prevalence having increased 2.5 times in the last 30 years, making it a leading cause of neurological disability. The hallmark of PD is a motor syndrome characterized by bradykinesia, resting tremor, and rigidity, alongside postural and gait alterations. Despite being considered a movement disorder, PD often presents non-motor symptoms like hyposmia, constipation, urinary dysfunction, orthostatic hypotension, cognitive impairments, mood depression, pain, and sleep disorders. Motor symptoms progressively impair daily activities and reduce quality of life, with difficulties in gait and swallowing worsening disability over time. Specifically, upper limb motor dysfunction is marked by reduced movement speed and impaired force modulation, leading to poor hand movement quality. Motor impairment in PD is inversely correlated with movement speed and directly correlated with task complexity.
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
- Parkinson Disease
- Being tested
- Experimental Group, control group
- Keywords
- Parkinson disease, Upper limb, Rehabilitation, Robotic-assisted therapy, Activities of Daily Living (ADL), Quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupDevice
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | 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. Receives: Device: Experimental Group |
| Control Group (CG) | Active comparator | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test (BBT)
Box and Blocks test, BBT, is used to measure a manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds. In Box and Blocks test there are test box with 150 blocks and a partition in the middle is placed lengthwise along the edge of a standard-height table. The test taker is instructed to quickly pick up one block at a time with his or her right or left hand. Then carry the box over the partitioned and drop it and it is important for the patient to know that each successful execution is one point and he or she carries two it will be counted as one. The number of blocks that the test taker successfully transferred will becomes the final score and the higher the score the better the gross manual dexterity of the test taker.
Measured: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Secondary outcomes (5)
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Lyle proposed that this hierarchical ordering would improve efficiency of testing, as normal movement on the most difficult items would be indicative of successful performance on proceeding items. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
Measured: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Unified Parkinson's Disease Rating Scale (UPDRS)
Unified Parkinson's Disease Rating Scale (UPDRS) is a rating tool used to gauge the the severity and progression of Parkinson's disease in patients. The UPDRS scale consists of the following six segments:
- Mentation, Behavior, and Mood;
- ADL;
- Motor sections;
- Complications of Therapy (in the past week);
- Modified Hoehn and Yahr Scale;
- Schwab and England ADL scale. The first four segments are made up of 42 items grouped into four subscales. The UPDRS was developed in 1987 as a gold standard by neurologists for monitoring the response to medications used to decrease the signs and symptoms of Parkinson's.
Parts 1 to 3 are scored on a 0-4 rating scale. Part 4 is scored with yes and no ratings. Higher scores show increased severity. Then the administrator rates the patient on the H and Y Scale and the Schwab and England Activities of Daily Living Scale.
Measured: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Disabilities of the Arm, Shoulder and Hand (DASH)
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The DASH has been translated in many different languages and has demonstrated to be a valid and reliable questionnaire for a variety of upper extremity disorders. High score corresponds to high level of arm disability.
Measured: Day 0 (T0 - baseline), day 50 (T1 - After treatment), day 140 (FU1 - 3 months after treatment Follow-Up)
Client satisfaction questionnaire
The Client satisfaction questionnaire investigates the subject's overall satisfaction with participating in the study. It consists of six questions with a score ranging from 0 to 4. A high score corresponds to a high level of satisfaction from the subject.
Measured: Day 50 (T1 - After treatment).
System Usability Scale (SUS)
The System Usability Scale (SUS) is a simple, ten-item scale giving a global view of subjective assessments of usability. SUS is a Likert scale. It is often assumed that a Likert scale is simply one based on forced-choice questions, where a statement is made and the respondent then indicates the degree of agreement or disagreement with the statement on a 5 (or 7) point scale. However, the construction of a Likert scale is somewhat more subtle than this. Whilst Likert scales are presented in this form, the statements with which the respondent indicates agreement and disagreement have to be selected carefully.
Measured: Day 50 (T1 - After treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start20 Dec 2023
- Primary completion14 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Prof. Marco Franceschini, MD, Study chair, IRCCS San Raffaele RomaProf. Marco Franceschini, MD, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906679
- Sponsor's protocol ID
- RP 12/23
- Acronym
- MOTORPARK
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be shared upon request from the Principal Investigator, Study Chair, or Central Contact Person of this study.
Publications
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.
PubMed 30879893Dorsey 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.
PubMed 30584159Tolosa 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.
PubMed 33894193Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PubMed 18344392Ponsen 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.
PubMed 17913560Quinn 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.
PubMed 23231827FITTS 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.
PubMed 13174710Sanes JN. Information processing deficits in Parkinson's disease during movement. Neuropsychologia. 1985;23(3):381-92. doi: 10.1016/0028-3932(85)90024-7.
PubMed 4022305Jankovic 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.
PubMed 19043519Peall 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.
PubMed 26210889Grazina 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.
PubMed 23492553Capecci 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.
PubMed 31377382Keus 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.
PubMed 24769288Molteni 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.
PubMed 30269804
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06906679
- Acronym / sponsor ID
- MOTORPARK / RP 12/23
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Upper limb, Rehabilitation, Robotic-assisted therapy, Activities of Daily Living (ADL), Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional rehabilitation treatment. The study protocol will involve individuals diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank criteria, who will be randomly assigned to one of the following groups:
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.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting over 6 million individuals worldwide, with its prevalence having increased 2.5 times in the last 30 years, making it a leading cause of neurological disability. The hallmark of PD is a motor syndrome characterized by bradykinesia, resting tremor, and rigidity, alongside postural and gait alterations. Despite being considered a movement disorder, PD often presents non-motor symptoms like hyposmia, constipation, urinary dysfunction, orthostatic hypotension, cognitive impairments, mood depression, pain, and sleep disorders. Motor symptoms progressively impair daily activities and reduce quality of life, with difficulties in gait and swallowing worsening disability over time. Specifically, upper limb motor dysfunction is marked by reduced movement speed and impaired force modulation, leading to poor hand movement quality. Motor impairment in PD is inversely correlated with movement speed and directly correlated with task complexity.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Device: Experimental GroupParticipants 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. |
| Control Group (CG) | Active comparator | Other: control groupParticipants 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 30 and 80 years;
- 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;
Key exclusion criteria (4 listed)
- Unable to adhere to the exercise program due to poor compliance;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupThe 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. | Device | Experimental Group (EG) |
| control groupThe 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. | Other | Control Group (CG) |
Primary outcome
Box and Block Test (BBT)
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Box and Blocks test, BBT, is used to measure a manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds. In Box and Blocks test there are test box with 150 blocks and a partition in the middle is placed lengthwise along the edge of a standard-height table. The test taker is instructed to quickly pick up one block at a time with his or her right or left hand. Then carry the box over the partitioned and drop it and it is important for the patient to know that each successful execution is one point and he or she carries two it will be counted as one. The number of blocks that the test taker successfully transferred will becomes the final score and the higher the score the better the gross manual dexterity of the test taker.
5 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment), day 140 (FU1 - 3 months after treatment Follow-Up)
Client satisfaction questionnaire
Time frame: Day 50 (T1 - After treatment).
System Usability Scale (SUS)
Time frame: Day 50 (T1 - After treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Results publication: PubMed 30879893GBD 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.
- Results publication: PubMed 30584159Dorsey 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.
- Results publication: PubMed 33894193Tolosa 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.
- Results publication: PubMed 18344392Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- Results publication: PubMed 17913560Ponsen 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.
- Results publication: PubMed 23231827Quinn 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.
- Results publication: PubMed 13174710FITTS 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.
- Results publication: PubMed 4022305Sanes JN. Information processing deficits in Parkinson's disease during movement. Neuropsychologia. 1985;23(3):381-92. doi: 10.1016/0028-3932(85)90024-7.
- Results publication: PubMed 19043519Jankovic 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.
- Results publication: PubMed 26210889Peall 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.
- Results publication: PubMed 23492553Grazina 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.
- Results publication: PubMed 31377382Capecci 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.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be shared upon request from the Principal Investigator, Study Chair, or Central Contact Person of this study.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Marco Franceschini, MD study chair
IRCCS San Raffaele Roma
Prof. Marco Franceschini, MD principal investigator
IRCCS San Raffaele Roma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 2 sites 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block Test (BBT) (time frame: Day 0 (T0 - baseline), day 50 (T1 - After treatment).). 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 NCT06906679, which also lists 15 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 19 Oct 2026.