An interventional study of AGREE exoskeleton and FEXO exoskeleton in Stroke and Neurologic Disorder, sponsored by Casa di Cura Privata del Policlinico SpA. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Casa di Cura Privata del Policlinico SpA · Not applicable, Interventional, and Health services research
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Among 345 studies in Stroke with a site in Italy — 92 open to participants now, 105 under way, 3 of them phase 3. Stroke · Italy.
Among the 345 studies in Stroke with a site in Italy, this one is the 169th largest by enrollment of the 263 interventional ones that give a count, is one of 30 that started in 2022, is one of 208 with no phase, and was the 195th registered.
8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →92 of the 345 studies in Stroke with a site in Italy are open now. Recruiting first, the newest first:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Sites in Italy
Ages 18+
Hospital Universitari Vall d'Hebron Research Institute · Sites in Italy, Belgium, Germany and 3 more countries
Ages 18+
Dr. Yaroslav Winter · Sites in Italy, Czechia, Germany and 1 more country
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna · Sites in Italy
Ages 18+
Azienda Unita Sanitaria Locale di Piacenza · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
345 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 30 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is close to the median of 49 across 6,027 interventional studies indexed under Stroke.
Median enrollment 72 across the 263 interventional studies, 250 across the 82 observational. Of the 193 that completed or were terminated, 33 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
63 of 345 have an industry lead sponsor. The 10 most frequent:
Casa di Cura Privata del Policlinico SpA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Casa di Cura Privata del Policlinico SpA has 3 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
34 of the studies in Stroke with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06547827Fondazione Don Carlo Gnocchi ETSRehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients | 2026-11 |
| NCT06710028Fondazione Policlinico Universitario Agostino Gemelli IRCCSTrustworthy Artificial Intelligence for Improvement of Stroke Outcomes | 2026-11-30 |
| NCT07670325Scuola Superiore di Studi Universitari e di Perfezionamento Sant'AnnaFuncitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients | 2026-11-30 |
| NCT04559724IRCCS San Raffaele RomaGait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes | 2026-12 |
| NCT07637123IRCCS San Raffaele RomaEvaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients | 2026-12 |
Add all 34 to your calendar (.ics) → With an account.
Among the 345 studies in Stroke with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Acquired cerebrovascular trauma is the third most common cause of disability worldwide, resulting in long-term disability, limitation of activities of daily living, and reduced social participation. It is estimated that, within three months of the acute event, a high percentage of patients do not recover full function. 93% of these disabilities concern the upper limb.
To induce optimal functional reorganization after the acute cerebrovascular events or neurodegenerative diseases affecting the central nervous system, robotic assistance allows intensive exercises with specific therapeutic purposes. Indeed, they enable an intensive, repetitive, and customizable therapeutic program that is in line with the principles underlying motor learning.
Clinical investigation is needed to assess the efficacy of the proposed new technologies (AGREE and FEXO exoskeleton) and to guide subsequent developmental steps. Therefore, an exploratory clinical study is proposed to evaluate usability, tolerability, and safety, as well as to assess the effectiveness of the new technologies.
The primary objective of this study is to examine the safety and tolerability of the new active exoskeletons for upper extremity rehabilitation and validate them in a controlled environment. Furthermore, efficacy will be examined as the secondary outcome.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 sessions, 3 sessions per week. Each session consists of 45 minutes of training with the AGREE exoskeleton. The training session is customized to the patient's needs and can be adapted to his/her improvement during the intervention.
Device: AGREE exoskeleton
15 sessions, 3 sessions per week. Each session consists of 45 minutes of training with the FEXO exoskeleton. The training session is customized to the patient's needs and can be adapted to his/her improvement during the intervention.
Device: FEXO exoskeleton
15 sessions, 3 sessions per week. Each session consists of 45 minutes and consists of different training modalities typically used in the rehabilitation of the arm after stroke.
Other: Conventional therapy
Upper limb exoskeleton with four actuated degrees of freedom (shoulder horizontal adduction/abduction, shoulder flexion/extension, humeral rotation, elbow flexion/extension), and one passive degree of freedom (wrist pronation/supination), implementing different rehabilitative strategies. The intervention consists of the execution of different exercises with the affected arm supported by the AGREE device. The subject is actively involved in the exercises and the system provides different kinds of assistance that can be tailored according to the patient's status. The following exercises can be performed: * anterior reaching (in a plane or in the space) * lateral elevation of the arm * hand to mouth movements with or without an object in the hand * moving objects (on a plane or in the space) * exergames. A subset of exercises is defined based on the patient's capability.
After patient's preparation (tDCS and FES) the FEXO assessment is conducted. The subject performs FEXO assessment games. This stage is also used to calibrate the reach and grasp movement intention EEG patterns. The movement is recorded using internal kinematic sensors; therefore, these measures can be extracted for both reaching and lifting movements. Trunk forward bending is measured to avoid compensatory movements when doing reaching assessment. The clinician then reviews the plan for today's session: game selection, number of repetitions and assistance levels. The patient gets ready to play the games and the clinician starts the first activity of the active stage of FEXO therapy. The patient plays the game and sees his own results. The clinician monitors patient activity, assistance levels, effort and signs of discomfort. The patient plays the next game and sees his own results, and the clinician checks the patient's progress with the results overview.
It consists of a combination of different treatment modalities among the following, based on the patient's specific needs: * Upper limb passive motion * Occupational therapy exercises * Constraint-induced movement therapy * Upper limb active movement (reaching, grasping, elevation, spatial orientation) * Repetitive task training
System Usability Scale (SUS)
SUS is used to measure how easy or difficult the proposed system is to use
Time frame: up to 5 weeks
Technology Assessment Methods (TAM)
TAM is an information systems theory that models how users come to accept and use a technology
Time frame: up to 5 weeks
Virtual Reality Questionnaire (VR)
VR is used to measure how easy or difficult the virtual reality interface is to use
Time frame: up to 5 weeks
Fugl-Meyer Assessment Scale (FMA-UE)
FMA-UE assesses sensorimotor status including items assessing upper extremity motion, balance, sensation and range of movement
Time frame: up to 5 weeks
Action Research Arm Test (ARAT)
ARAT is used to assess upper extremity performance (coordination, dexterity and functioning)
Time frame: up to 5 weeks
Modified Ashworth Scale (MAS)
MAS is used to muscle quantified spasticity
Time frame: up to 5 weeks
Motricity Index (MI)
MI is used to grade motor activity in muscles of the upper limb
Time frame: up to 5 weeks
Visual Analogue Scale (VAS)
VAS is a psychometric response scales used to measure subjective pain
Time frame: up to 5 weeks
Box and Block Test (BBT)
BBT measures unilateral gross manual dexterity. The BBT administration consists of asking the subject to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds
Time frame: up to 5 weeks
Nine Hole Peg Test (9HPT)
9HPT is used to measure finger dexterity in patients. The 9HPT administration consist of asking the subject to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible
Time frame: up to 5 weeks
Number of Peaks (#Peaks) of the speed profile
If a point-to-point reaching movement has a low number of peaks, it means that few acceleration and deceleration periods are present
Time frame: up to 5 weeks
Smoothness described by the Teulings's index (TI)
TI s the rate of change of the acceleration in a movement; a lower value of TI indicates a smoother movement
Time frame: up to 5 weeks
The absolute hand path error (e)
e is the area between the actual movement path and the straight line; this was considered an index of learning and a reduction of e indicates a better adaptation to the required task.
Time frame: up to 5 weeks
Event-Related Desynchronization and Synchronization (ERD/ERS) of the μ and β rhythms
Motor processing can result in changes of the ongoing EEG in form of an event-related desynchronization (ERD) or event-related synchronization (ERS). Spatial mapping of ERD/ERS can be used to study the dynamics of cortical activation patterns
Time frame: up to 5 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Mar 2023, 14 months.
Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 14 months is below that.
Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Casa di Cura Privata del Policlinico SpA