StrokeRONDANCT07316218
Personalized Wearable Robotics for Upper-limb Motor Rehabilitation in Neurological Patients. A Pilot Study.
A study testing Robotic treatment - NESM alpha in people with Stroke, run by Federico Posteraro at 1 site in Italy.
Trial summary
The study is designed as an open-label pilot study with a pre-post treatment assessment. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic treatment - NESM alpha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 13 Nov 2024to 14 Mar 2025
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral ischemic or hemorrhagic stroke, sub-acute (<6 months) or chronic (>6 months)
- Severe spasticity (MAS ≥ 2) or mild-moderate spasticity with residual active antigravity movements (MAS < 2)
- Fugl-Meyer upper extremity score ≤ 42
- MMSE > 24
- No severe pain during passive mobilization
- Written informed consent
Who cannot join
- Unstable clinical conditions
- Inability to maintain sitting posture
- Pacemaker or other implanted electronic devices
- Passive range of motion < 10°
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed as an open-label pilot study with a pre-post treatment assessment.
Read the detailed description
The enrolled patients will undergo a rehabilitation program aimed at recovering upper-limb motor function. The entire cohort will receive the hospital's standard rehabilitative care, and the experimental treatment will be provided as an add-on. All participants will complete 7 sessions of robot-assisted rehabilitation (consecutive where possible, for a maximum of 5 sessions per week), with the NESM-α robotic exoskeleton. Robotic treatment consists of sessions focused on shoulder and elbow mobilization and functional movements. The range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities.
- Conditions
- Stroke
- Being tested
- Robotic treatment - NESM alpha
- Keywords
- Stroke, Pilot Study, Exoskeleton
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic treatment - NESM alphaDevice
The NESM-α exoskeleton can deliver passive mobilization or active-assist support that follows the patient's voluntary motion. The joints' range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities.
| Study group | Role | What they receive |
|---|---|---|
| NESM-alpha | Experimental | Patients with severe or moderate upper-limb motor impairment (UEFM ≤ 42) receive 7 sessions of robot-assisted shoulder-elbow mobilization (consecutive where possible, for a maximum of 5 sessions per week) in addition to standard rehabilitation. During the first and last session, the patients' residual capabilities are assessed though robotic-aided assessments as well as with clinical scales. Receives: Device: Robotic treatment - NESM alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Safety of the delivered treatment is assessed monitoring the number of Adverse Events (AE). The metric is the number of events.
Measured: from enrollment to the end of treatment (up to 2 weeks)
Feasibility of recruitment and retention
Evaluate the number of patients that were recruited and retained for the full study period. Evaluate the number of drop-out.
Measured: Day 7
Secondary outcomes (6)
Patient's functionality
Patient's functionality is assessed with Fugl-Meyer Assessment. It ranges from 0-66 with 0 indicating no funcionality, and 66 normal motor function.
Measured: Days 1 and 7
Patient's Spasticity
Patient's spasticity is assessed with the Modified Ashworth Scale (MAS). It rates spasticity (muscle tone) during passive stretch.
Range: 0, 1, 1+, 2, 3, 4. Direction: 0 = no increase in tone (best); 4 = rigid in flexion/extension (worst).
Measured: Days 1 and 7
Patient's Motor Function
Patient's motor function is assessed with the Wolf Motor Function Test (WMFT). It assesses upper-limb motor function via 15 timed tasks plus strength measures.
Performance Time: seconds to complete each task (often capped at 120 s if not completed). Lower = better.
Measured: Days 1 and 7
Patient's Pain
Patient's pain is assessed with the Numeric Pain Rating Scale (NPRS). Range: 0-10 (integer or 0.5 steps). Direction: 0 = no pain (best); 10 = worst imaginable pain (worst).
Measured: Days 1 and 7
Joint Angles
Kinematic performance of the patient using the robot is assessed with the spanned joints angles (measured in degrees)
Measured: Days 1 and 7
Joint Torques
Kinematic performance of the patient using the robot is assessed with the joint torques (measured in Nm) exchanged with the robot
Measured: Days 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start13 Nov 2024
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Traditional feasibility study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico Posteraro
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor-investigator, Federico Posteraro, Azienda USL Toscana Nord Ovest
- Investigators
- Federico Posteraro, Principal investigator, ASL Nord Ovest Toscana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316218
- Sponsor's protocol ID
- RONDA201813581
- Other IDs
- PAR FAS 2007-2013
- Acronym
- RONDA
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Wearable Robotics for Upper-limb Motor Rehabilitation in Neurological Patients. A Pilot Study.
- ClinicalTrials.gov ID
- NCT07316218
- Acronym / sponsor ID
- RONDA / RONDA201813581
- Conditions
- Stroke
- Keywords
- Stroke, Pilot Study, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Federico PosteraroUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 5 Jan 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.
The study is designed as an open-label pilot study with a pre-post treatment assessment.
Detailed description
The enrolled patients will undergo a rehabilitation program aimed at recovering upper-limb motor function. The entire cohort will receive the hospital's standard rehabilitative care, and the experimental treatment will be provided as an add-on. All participants will complete 7 sessions of robot-assisted rehabilitation (consecutive where possible, for a maximum of 5 sessions per week), with the NESM-α robotic exoskeleton. Robotic treatment consists of sessions focused on shoulder and elbow mobilization and functional movements. The range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Traditional feasibility study
| Arm | Type | Receives |
|---|---|---|
| NESM-alpha | Experimental | Device: Robotic treatment - NESM alphaPatients with severe or moderate upper-limb motor impairment (UEFM ≤ 42) receive 7 sessions of robot-assisted shoulder-elbow mobilization (consecutive where possible, for a maximum of 5 sessions per week) in addition to standard rehabilitation. During the first and last session, the patients' residual capabilities are assessed though robotic-aided assessments as well as with clinical scales. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral ischemic or hemorrhagic stroke, sub-acute (<6 months) or chronic (>6 months)
- Severe spasticity (MAS ≥ 2) or mild-moderate spasticity with residual active antigravity movements (MAS < 2)
- Fugl-Meyer upper extremity score ≤ 42
- MMSE > 24
- No severe pain during passive mobilization
Key exclusion criteria (4 listed)
- Unstable clinical conditions
- Inability to maintain sitting posture
- Pacemaker or other implanted electronic devices
- Passive range of motion < 10°
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 |
|---|---|---|
| Robotic treatment - NESM alphaThe NESM-α exoskeleton can deliver passive mobilization or active-assist support that follows the patient's voluntary motion. The joints' range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities. | Device | NESM-alpha |
Primary outcome
Number of adverse events
Time frame: from enrollment to the end of treatment (up to 2 weeks)
Safety of the delivered treatment is assessed monitoring the number of Adverse Events (AE). The metric is the number of events.
Feasibility of recruitment and retention
Time frame: Day 7
Evaluate the number of patients that were recruited and retained for the full study period. Evaluate the number of drop-out.
6 secondary outcomes
Patient's functionality
Time frame: Days 1 and 7
Patient's Spasticity
Time frame: Days 1 and 7
Patient's Motor Function
Time frame: Days 1 and 7
Patient's Pain
Time frame: Days 1 and 7
Joint Angles
Time frame: Days 1 and 7
Joint Torques
Time frame: Days 1 and 7
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 5 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Federico Posteraro principal investigator
ASL Nord Ovest Toscana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic treatment - NESM alpha in people with Stroke, run by Federico Posteraro 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 6 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 5 Jan 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?
Number of adverse events (time frame: from enrollment to the end of treatment (up to 2 weeks)). The study lists 2 primary outcomes in all. 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 5 Jan 2026.