An observational study in Healthy, Parkinson Disease and Stroke, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Open to participants aged 35 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by IRCCS San Raffaele Roma · Observational
This study aims not only to develop a standardized protocol for performing the targeted BBT but also to assess synchronized parameters: kinematic (using IMUs) and electrophysiological (EMG) data. In this context, the pilot study aims to standardize the instrumented BBT for the objective evaluation of joint kinematics and muscle activations in the upper limb of healthy subjects. After establishing normative movement data, the study will focus on characterizing pathological upper limb movements in individuals with Parkinson's disease and post-stroke, comparing the obtained data with normative references.
Upper limb impairment can result from various conditions, including stroke, Parkinson's disease, musculoskeletal disorders, and cerebral palsy. Patients undergoing upper limb rehabilitation are typically assessed using functional and motor scales to evaluate therapy effectiveness and disease progression over time. These assessments focus on daily living activities (ADLs), dexterity, and strength.
Several validated tests exist for evaluating upper limb disability. The Jebsen-Taylor Hand Function Test measures ADL performance, such as eating, picking up small objects, and card turning , where faster completion times indicate better function. The Action Research Arm Test assesses grasping, moving, and releasing objects across 19 tasks, scored from 0 to 3 by an observer. The Box and Blocks Test (BBT) is widely used to assess manual dexterity across different clinical populations, including post-stroke, multiple sclerosis, traumatic brain injury, and upper limb amputation. The BBT score is determined by the number of wooden cubes (2.5 cm³) moved over a partition in one minute. Despite its ease and ecological validity, traditional clinical tests only partially assess movement quality.
Motion Capture (MoCap) technology enables a detailed, quantitative kinematic analysis of upper limb movement, typically using marker-based stereophotogrammetry and infrared cameras. Studies have demonstrated MoCap's utility for analyzing upper limb movement in post-stroke patients and ADL performance. However, few studies have integrated MoCap into clinical tests to analyze kinematics during repetitive motor tasks. These studies found high trajectory variability in the BBT due to random block placement and unrestricted selection.
To address this variability, has been introduced two standardized BBT versions:
Modified BBT (mBBT): Subjects pick up 16 blocks from a 4x4 grid in a set order, transport them over the partition, and drop them.
Targeted BBT (tBBT): Blocks must be placed precisely onto a grid beyond the partition, mimicking real-world object manipulation.
Early results from MoCap-based analysis of these BBT variants indicate feasibility and standardized movement trends in healthy young adults. However, limitations exist, such as the study's focus on young adults (29.9±8.3 years) and testing in a standing position.
An alternative kinematic analysis approach uses Inertial Measurement Units (IMUs), which provide accurate motion tracking with minimal setup outside lab environments. IMUs have been used in upper limb movement analysis, including clinical assessments for multiple sclerosis, post-stroke, and Parkinson's disease.
Beyond kinematics, superficial electromyographic (sEMG) analysis evaluates muscle activation and co-contraction during motor tasks highlighting the importance of multimodal evaluations combining biomechanical and electrophysiological data.
This study aims to develop a standardized protocol for the targeted BBT, integrating synchronized kinematic (IMU) and electrophysiological (sEMG) measurements. The pilot phase will define normative movement patterns in healthy individuals before analyzing pathological upper limb movements in Parkinson's disease and post-stroke patients, comparing them against normative data.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 105 is close to the median of 97 across 1,081 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →IRCCS San Raffaele Roma is the lead sponsor of 68 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Thirty-five able-bodied adults (Control Group, CG), thirty-five individuals with PD (Parkinson Group, PG), and thirty-five individuals with stroke (Stroke Group, SG) will be recruited among inpatients and outpatients of the IRCCS San Raffaele (Rome, Italy).
All participants who have signed the informed consent for the study and meeting the inclusion and exclusion criteria will be considered eligible. Each of the participants belonging to the three groups has to meet the following inclusion and exclusion criteria:
Control group (CG)
Inclusion Criteria:
Exclusion Criteria:
Parkinson group (PG)
Inclusion Criteria:
Exclusion Criteria:
Stroke group (SG)
Inclusion Criteria:
Exclusion Criteria:
Healthy subjects without any upper limb disorder, adults and collaborative.
Other: Inertial Measurement Unit and Box and Block test
subjects with Parkinson disease, collaborative, able to understand and perform the required motor activity withs UPDRS 8, 9, 10, 11, 12, 16: value 2 or 3 or UPDRS 20, 21, 22, 23, 24, 25: value 2 or 3.
Other: Inertial Measurement Unit and Box and Block test
post-stroke subjects with neurological impairments of the upper limb, collaborative, able to understand and perform the required motor activity, moderate hemiparesis measured with the Fugl-Meyer Assessment Upper Limb (FM-UL) (22\<FM-UL≤44) or mild hemiparesis (FM-UL\>44), Modified Ashworth Scale (MAS) score of the main components (shoulder, elbow, and wrist) of the upper limb \<3.
Other: Inertial Measurement Unit and Box and Block test
Subjects will be assessed during Standard Box and Block Test and Targeted Box and Block Test with Inertial Measurement Units. The subject is seated on a stable stool (without backrest and armrests) adjustable in height so that the hip and knee angles are formed at 90°. A height-adjustable table is placed in front of the subject: the heights of the table and the seat are adjusted so that the subject forms 90-degree elbow angles by resting the forearms on the table. The standardized BBT box (53.7 x 25.4 x 8.5 cm) is placed on the table so that the 15.2 cm high division is in correspondence with the medio-lateral axis of the subject and at a distance such that the subject reaches the (X0,Y0) of the box with the distal point of the metacarpal bone of the middle finger. Once the system has been calibrated and the inertial sensors applied, the patient will be asked to perform the task
IMU-based targeted Box and Block Test (t-BBT)
Instrumental assessment of manual dexterity will be conducted using a sensorized and targeted BBT (tBBT): 16 wooden blocks, 2.5cm3 in size, are placed on a 4x4 grid in the container closest to the limb to be assessed. The subject must grasp one block at a time with a pre-established order (numbering in figure 2), transfer it over the dividing wall and release it on the corresponding position of a 4x4 grid present in the other container, as quickly as possible. Acquisition duration: time necessary to complete the exercise. After 2 minutes the acquisition is however interrupted.
Time frame: Baseline
Standard BBT
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box should be oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. In order to practice and register baseline scores, the test should begin with the unaffected upper limb.
Time frame: Baseline
Passive Range of Motion (ROM)
Range Of Motion (ROM) is the arc of motion available at a single joint or series of joints. It is the angle through which the joint moves from the anatomical position to the extreme limit of its motion in a particular direction. In essence, it is the extent to which a part of the body can be moved around a joint or a fixed point.
Time frame: Baseline
Hoehn & Yahr (H&Y)
The scale has been used for the staging of the functional disability associated with Parkinson's disease. It helps in describing the progression of the disease through various stages, thus allowing us to measure the severity of the case. 1 Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement 2 Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test 3 Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent 4 Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted 5 Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided
Time frame: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS): UPDRS (2) e (3)
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. 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\[1\]. The UPDRS scale consists of the following six segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Complications of Therapy (in the past week) 5) Modified Hoehn and Yahr Scale, and 6) 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.
Time frame: Baseline
Freezing Of Gait Questionaire (FOGQ)
The FOGQ assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The NFOG-Q doesn't require any equipment and is simple to administer. When rating the frequency of FOG over the previous month, patients independently complete the questionnaire, reporting both ON and OFF medication states. Responses to all but item 1 are added up to determine the final score, which ranges from 0 to 28. Higher ratings indicate greater impact and intensity of freezing episodes. Patients who respond negatively to item 1, which functions as a screening question, may be categorised as non-freezers.
Time frame: Baseline
Frenchay-Activities-Index (FAI)
The aim is to record activities which require some initiative from the patient. It is important to concentrate upon the patient's actual frequency of activity over the recent past, not distant past performance nor potential performance. One activity can only score on one item. The frequency with which each item or activity is undertaken over the past 3-6 months (depending on the nature of the activity) is assigned a score of 1 - 4 where a score of 1 is indicative of the lowest level of activity. The scale provides a summed score from 15 - 60.
Time frame: Baseline
Fugl-Meyer Assessment Upper Limb (FM-UL)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. it is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is divided in Upper and Lower limb assesment. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score for the Fugl-Meyer Assesment for Upper Limb is 126 points.. Points are divided among the domains as follows: Motor score: ranges from 0 (hemiplegia) to 66 points (normal motor performance); Sensation: ranges from 0 to 12 point; Joint range of motion: ranges from 0 to 24 point; Pain: from 0 to 24 point.
Time frame: Baseline
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is used to assess spasticity.The Modified Ashworth Scale (MAS) is used to assess spasticity. The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Joint angles are measured in degrees.
Time frame: Baseline
Plan to share: Undecided — Data will be shared upon direct request to the study Principal Investigator following the Local Ethics Committee approval.
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jan 2025, 60 months.
Of 381 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's 60 months is above that.
Counting every sponsor, half of 440 studies reached it within 48 months; a quarter within 21 and three quarters within 112.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IRCCS San Raffaele Roma