A Phase 2 interventional study of Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS) in Cerebrovascular Accident (CVA), Chronic Disease and Stroke Rehabilitation, sponsored by Scuola Superiore Sant'Anna di Pisa. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-13.
Sponsored by Scuola Superiore Sant'Anna di Pisa · Phase 2, Interventional, and Treatment
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 221st largest by enrollment of the 263 interventional ones that give a count, is one of 18 that started in 2016, is one of 8 in phase 2, and was the 116th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 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
Hospital Universitari Vall d'Hebron Research Institute · Sites in Italy, Belgium, Germany and 3 more countries
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
Azienda Unita Sanitaria Locale di Piacenza · Sites in Italy
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, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 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. 18 started in 2016.
This study's enrollment of 26 is below the median of 49 across 6,024 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.
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63 of 345 have an industry lead sponsor. The 10 most frequent:
Scuola Superiore Sant'Anna di Pisa is the lead sponsor of 2 studies on the registry; none are open to participants now.
Scuola Superiore Sant'Anna di Pisa has 1 study 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 |
Among the 345 studies in Stroke with a site in Italy, from their registry updates:
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The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.
Inclusion Criteria:
The conventional treatment arm was conducted according to a set of exercises that were specifically designed in order to match the robotic treatment. Patients received both physical therapy (PT) and occupational therapy (OT) session, administered by the physiotherapists of the hospital. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals.
The patients enrolled in the robotic arm are going to be undergone a series of passive, assisted and active mobilization in upper limb task-oriented exercises implemented in 3d virtual environments. Briefly speaking, these tasks promote the upper arm multi-joints coordination during the execution of reaching movements and grasping actions of fixed virtual objects displaced in the space.
Device: Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)
RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.
Change in Fugl-Meyer Assessment (FMA( Score
The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.
Time frame: baseline and 6 weeks
Functional scale: Bimanual Activity Test (BAT)
The BAT is a functional scale designed to quantify the contribution of patient's affected upper limb to execute 25 common Activities of Daily Living such as Loosen and tighten the cap of a bottle , or unscrew a bolt. The elapsed time for accomplishing each task is measured and the therapist also give a score (ranging from 1 to 4) about the quality of each movement. The BAT data is analyzed also in terms of sub-items, divided into pinch-tasks and power-tasks collecting those items requiring fine and gross manipulation motor skills respectively.
Time frame: baseline and 6 weeks
Modified Ashworth (MA) scale
The MA scale (Bohannon and Smith, 1987) is used to evaluate spasticity of the upper limb and to assess abnormal muscle tone at the shoulder and elbow. The MA scale is a 6-point scale: scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. MA scores were averaged across the two joints and across testing directions (flexion, extension) to estimate abnormal muscle tone in the upper extremity (Zackowski, Dromerick et al., 2004)
Time frame: baseline and 6 weeks
Robotic kinesiological assessment of movement: Execution Time
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The execution time is measured as the elapsed time (measure in seconds) for accomplishing each movement, measured from the time of grasping of the virtual object at the start position to the release time at the target position.
Time frame: At end of each session, during 6 weeks of enrollment in treatment
Robotic kinesiological assessment of movement: Smoothness index
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The smoothness index is computed in the same interval period by counting the number of peaks in the velocity profile of movement, namely the Number of Movements Units (NMU) (Fasoli S, Krebs J Neurosci 2002)
Time frame: At end of each session, during 6 weeks of enrollment in treatment
Plan to share: Undecided — De-identified individual participant data for all primary and secondary outcome measures will be made available
Ran from Jul 2016 to primary completion in Oct 2018, 27 months.
Of 113 non-industry phase 2 interventional studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's 27 months is below that.
Counting every sponsor, half of 133 studies reached it within 40 months; a quarter within 24 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Scuola Superiore Sant'Anna di Pisa