An interventional study of STANDARD REHAB and SONICHAND in Stroke and Hand Injuries, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 4 sites in Italy. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Treatment
Among 10 studies in Stroke by Istituti Clinici Scientifici Maugeri SpA — 6 open to participants now, 6 under way, none of them phase 3. Stroke · Istituti Clinici Scientifici Maugeri SpA.
Among the 10 studies in Stroke by Istituti Clinici Scientifici Maugeri SpA, this one is the only one that started in 2017, is one of 8 with no phase, and was the 1st registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
Browse Stroke studies →6 of the 10 studies in Stroke by Istituti Clinici Scientifici Maugeri SpA are open now, in 1 country. Recruiting first, the newest first:
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 40–85 · Healthy volunteers
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages up to 80
By country, each count listing its studies:
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: 40 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.
10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2017.
This study's enrollment of 65 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Median enrollment 105 across the 8 interventional studies, 218 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.
3 of the studies in Stroke by Istituti Clinici Scientifici Maugeri SpA that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07254390Istituti Clinici Scientifici Maugeri SpAEffects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training | 2026-12-20 |
| NCT05706831Istituti Clinici Scientifici Maugeri SpAMusic Intervention and Transcranial Electrical Stimulation for Neurological Diseases | 2026-12-31 |
| NCT04876339Istituti Clinici Scientifici Maugeri SpASonification Techniques for Gait Training | 2026-12-31 |
Among the 10 studies in Stroke by Istituti Clinici Scientifici Maugeri SpA, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study uses a specific hand tracking sensor (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined musical patterns (sonification) in a neurologic music therapy perspective. The aim of the experiment is to verify the efficacy of sonification technique (compared to usual care) in the hand rehabilitation of patients with stroke.
Introduction:
Every year in Italy occur over than 200.000 new stroke cases. The virtual and augmented reality offers a valid support to the rehabilitation program by providing objectives parameters for the patient evaluation, accelerating the motor recovery process and enhancing the motor performance after the discharge. This study uses a specific hand tracking sensor (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined musical patterns (sonification) in a neurologic music therapy perspective.
In addition to its use in relational contexts, in fact, music therapy is widely used in the field of rehabilitation, and in particular in the neuromotor rehabilitation, due to the impact of the sound, as well as on paralimbic and limbic areas, the areas of the brain involved in the movements (motor cortex, supplementary motor area, cerebellum, basal ganglia, etc.).
Recent studies uses sonification for the rehabilitation of the upper limbs assuming a replacement of the proprioceptive aspects damaged by the disease thanks to the audio-motor feedback. This study, furthermore, exploits the specificities of the Leap Motion Controller and the peculiarities of the sound stimuli that accompany the arm movement without requiring cognitive tasks.
Objectives:
Materials and Methods:
In this randomized controlled trial 66 patients with stroke will be recruited and allocated in 2 groups. The control group will be undergone to a 35 minutes standard daily rehabilitation treatment lasting 4 weeks. The experimental group will be undergone to an analogue treatment based on 15 minutes of standard rehabilitation and 20 minutes of exercises with sonification. Randomisation will be centralized for the four Units involved in the study.
The intervention will be assessed in blind at the baseline (T0), at the mid-treatment period (T1 = 2 weeks), at the end of the treatment (T2 = 4 weeks), and at a follow-up point (T3 = 8 weeks).
The following assessment tools will be used:
At T0, T1, T2 and T3 some motion parameters will be recorded and monitored by the Leap Motion Controller to evaluate possible changes in the movements execution.
Statistics:
The Intention-To-Treat (ITT) population will be considered for the analysis. An unpaired Student's t test on the pre (T0)-post treatment (T2) differences will be used to assess the primary endpoint. Longitudinal trends over time will be assessed through repeated measures analysis of variance. Other analyses will be available in the statistical analysis plan.
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises (4 weeks, daily)
Device: SONICHAND
The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training for 4 weeks (daily)
Other: STANDARD REHAB
The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training with at least 6 exercises selected from: wrist * ulnarization radialization * prono-supination * horizontal flexion-extension * vertical flexion-extension hand * grasping * pinching * extensors * interosseous shoulder-elbow * vertical flexion-extension * push forward
The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises selected from the list. The Leap Motion Controller is managed with an ad-hoc developed application that is able to associate the movements with a 4 notes arpeggio or with a modulated texture. With the first mode the movement produces and modulates an harmonic progression built on the consecutive grades of the major scale played as ascending and descending arpeggio with also a volume crescendo and decrescendo. With the second mode, the movement modulates the volume and the low-pass cutoff frequency of a synthetic texture.
Fugl-Meyer Motor Assessment Scale
Primary endpoint of the study is given by the measurement of proximal and distal upper limb motor skills assessed by the Fugl-Meyer Motor Assessment Scale. The primary endpoint will be assessed by comparing the variation between T0 and T2 of the scale scores above mentioned in the experimental and control groups.
Time frame: 4 weeks
Box and Block Test (BBT)
Assessment of unilateral gross manual dexterity
Time frame: up to 8 weeks
Modified Ashworth Scale
Measurement of spasticity
Time frame: up to 8 weeks
Visual Analogue Scale (VAS)
Evaluation of perceived fatigue
Time frame: up to 8 weeks
Numerical Pain Rating Scale (NPRS)
Assessment of pain intensity
Time frame: up to 8 weeks
McGill Quality of Life
Assessment of Quality of Life
Time frame: up to 8 weeks
Plan to share: No
Ran from Mar 2017 to primary completion in May 2019, 25 months.
Of 3,108 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 25 months is close to that.
Counting every sponsor, half of 3,252 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 Apr 2021. 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.
Istituti Clinici Scientifici Maugeri SpA →