HealthyBBT_MOCAPNCT07883174
Motion Capture in Box and Bloks Test
An observational study of Healthy and Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Parkinson Disease, Stroke
- What is being tested?
- Inertial Measurement Unit and Box and Block test
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2020to 14 Feb 2025
- Phase
- Observational
- 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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- Age between 35 and 85 years old;
- Right-handed.
- diagnosis of idiopathic PD by UK Brain Bank criteria;
- Hoehn and Yahr (H\&Y) stage 2-3;
- aged between 35 and 85 years old;
- moderate disease-related upper limb motor performance deficit (i.e., Unified Parkinson's Disease Rating Scale (UPDRS) Part II, items 8, 9, 10, 11, 12, 16 =2-3; Unified Parkinson's Disease Rating Scale (UPDRS) Part III, items 20, 21, 22, 23, 24, 25 =2-3).
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- hemiparesis evaluated
- Fugl-Meyer Assessment Upper Limb (FMA-UL) ranging between moderate (22<FMA-UL<44) to mild (FMA>44);
- site of the cortical/subcortical lesion according to Bamford's classification: total anterior circulation infarct (TACI) and partial rior circulation infarct (PACI).
Who cannot join
- having pathologies affecting the upper limb function;
- having cognitive and/or severe visual deficit.
- Parkinson group (PG)
- inability to understand study instructions;
- severe visual deficit;
- coexisting disabling neurological or orthopedic disorders at upper limb;
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- previous brain surgery.
- Stroke group (SG)
- motor and cognitive inability to maintain the correct position during the execution time of the motor task;
- severe visual impairment;
- upper limb pain;
- site of the lesion according to Bamford's classification: posterior circulation infarct (POCI) and lacunar infarct (LACI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Analyzing Upper Limb Kinematics With Motion Capture During the Box and Blocks Test: Normative Data and Data From Subjects With Parkinson's Disease
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.
Read the detailed description
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.
- Conditions
- Healthy, Parkinson Disease, Stroke, Upper Extremity Paresis, Adults
- Being tested
- Inertial Measurement Unit and Box and Block test
- Keywords
- parkinson desease, stroke, upper limb, Inertial Measurement Units, assessment, box and block test
- Medical subject headings
- Parkinson Disease, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inertial Measurement Unit and Box and Block testOther
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects without any upper limb disorder, adults and collaborative. Receives: Other: Inertial Measurement Unit and Box and Block test | |
| Subjects with Parkinson disease | 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. Receives: Other: Inertial Measurement Unit and Box and Block test | |
| Post-stroke subjects | 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. Receives: Other: Inertial Measurement Unit and Box and Block test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start12 Jan 2020
- Primary completion14 Jan 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanaz Pournajaf, DPT, PhD, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883174
- Sponsor's protocol ID
- RP 19/34
- Acronym
- BBT_MOCAP
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon direct request to the study Principal Investigator following the Local Ethics Committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Analyzing Upper Limb Kinematics With Motion Capture During the Box and Blocks Test: Normative Data and Data From Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07883174
- Acronym / sponsor ID
- BBT_MOCAP / RP 19/34
- Conditions
- Healthy, Parkinson Disease, Stroke, Upper Extremity Paresis, Adults
- Keywords
- parkinson desease, stroke, upper limb, Inertial Measurement Units, assessment, box and block test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 20 Oct 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Inertial Measurement Unit and Box and Block testHealthy subjects without any upper limb disorder, adults and collaborative. |
| Subjects with Parkinson disease | – | Other: Inertial Measurement Unit and Box and Block testsubjects 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. |
| Post-stroke subjects | – | Other: Inertial Measurement Unit and Box and Block testpost-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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (9 listed)
- Age between 35 and 85 years old;
- Right-handed.
- diagnosis of idiopathic PD by UK Brain Bank criteria;
- Hoehn and Yahr (H\&Y) stage 2-3;
- aged between 35 and 85 years old;
Key exclusion criteria (12 listed)
- having pathologies affecting the upper limb function;
- having cognitive and/or severe visual deficit.
- Parkinson group (PG)
- inability to understand study instructions;
- severe visual deficit;
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 |
|---|---|---|
| Inertial Measurement Unit and Box and Block testSubjects 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 | Other | Healthy subjects, Post-stroke subjects, Subjects with Parkinson disease |
Primary outcome
IMU-based targeted Box and Block Test (t-BBT)
Time frame: Baseline
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.
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 20 Oct 2026.
- Individual participant dataSharing planned: Undecided. Data will be shared upon direct request to the study Principal Investigator following the Local Ethics Committee approval.
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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.
Sanaz Pournajaf, DPT, PhD principal investigator
IRCCS San Raffaele Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site 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 9 inclusion and 12 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 20 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 1 site 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?
IMU-based targeted Box and Block Test (t-BBT) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.