An interventional study of Serious Game and Conventional Therapy in Cerebral Palsy and Dyspraxia, sponsored by Scuola Superiore Sant'Anna di Pisa. Completed at 1 site in Italy. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by Scuola Superiore Sant'Anna di Pisa · Not applicable, Interventional, and Treatment
Among 59 studies in Cerebral Palsy with a site in Italy — 23 open to participants now, 23 under way, none of them phase 3. Cerebral Palsy · Italy.
Among the 59 studies in Cerebral Palsy with a site in Italy, this one is the 30th largest by enrollment of the 31 interventional ones that give a count, is one of 7 that started in 2017, is one of 25 with no phase, and was the 12th registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
Browse Cerebral Palsy studies →23 of the 59 studies in Cerebral Palsy with a site in Italy are open now. Recruiting first, the newest first:
LIFE - Research and Care Institute - Santa Lucia IRCCS · Sites in Italy
IRCCS Eugenio Medea · Sites in Italy
IRCCS Fondazione Stella Maris · Sites in Italy
IRCCS Eugenio Medea · Sites in Italy
IRCCS Fondazione Stella Maris · 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 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 6 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 7 started in 2017.
This study's enrollment of 8 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Median enrollment 44 across the 31 interventional studies, 80 across the 28 observational. Of the 32 that completed or were terminated, 4 (13%) have results posted.
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6 of 59 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 Cerebral Palsy — fewer than ten, so there is no comparison to draw.
7 of the studies in Cerebral Palsy 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 |
|---|---|
| NCT06622655IRCCS Eugenio MedeaClinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy | 2026-11 |
| NCT07793032IRCCS Fondazione Stella MarisExperimental Validation of the Virtual Eggs Test (VET) in the Pediatric Population | 2026-11-30 |
| NCT07902466LIFE - Research and Care Institute - Santa Lucia IRCCSShort-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy | 2026-12 |
| NCT06798233Azienda USL Reggio Emilia - IRCCSDevelopment and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire | 2026-12 |
| NCT06288971IRCCS Fondazione Stella MarisPersonalized Innovative Intervention Pathways to Promote EF in Children With CP | 2027-01-31 |
Among the 59 studies in Cerebral Palsy with a site in Italy, from their registry updates:
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The investigators proposed a controlled, single-blind, unicentric, crossover, randomized, clinical trial to test the effects of immersive virtual environments and wearable haptic devices in the rehabilitation of children with neuromotor impairments. In addition, the proposed approach was compared with respect to conventional therapy.
A sample of 8 participants was randomly divided into 2 groups and they attended one of the two therapeutic approach for 4 weeks before crossing over and inverting the therapy. Between the two interventions, there was a wash out period of 4 weeks.
The investigators assessed motor abilities of the children with validated clinical scales and motion analysis before/after each phase of the study (T0: baseline, T1: after 4 weeks, T2: after 8 weeks, T3: after 16 weeks, and T4: up to 24 weeks).
A Randomized Controlled Crossover Trial was designed to examine the usability and effectiveness of serious games and wearable haptic interfaces in rehabilitation of children with neuromotor impairments. The ethics board of Tuscany Region and the Italian Ministry of Health approved this study. All parents freely accepted the participation of their children in the study and provided written informed consent.
The investigators recruited eight patients, both male and female, 3 children with Cerebral Palsy (CP) and 5 children with Developmental Dyspraxia (DD) (mean age = 10,30±2,88 years), who were currently receiving conventional therapy at Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, and eight Typically Developing children (TD, mean age = 9,60±2,61 years). All the patients were right-handed and they did not have previous experiences with Virtual Reality (VR) and/or haptic devices, while TD children have previously experienced with commercial video games.
Following recruitment, screening and consent and baseline assessments, participants are randomized to an order of VR-assisted rehabilitation (ISG-Group, Immediate Serious Games, or DSG-Group, Delayed Serious Games). Participants were setup in their first condition and were assessed at the end of the 4 week intervention. Participants were then set up in their second period for 4 weeks, again with assessment occurring at the end of the intervention. Among the two interventions, a wash out period of 4 weeks was inserted and children followed only cognitive therapy with no physical sessions.
The study protocol consisted of a total of 16 sessions with both VR-assisted and conventional rehabilitation (2 sessions per week for 4 weeks for 2 periods) and involved a familiarization and a training phase. The investigators adopted different established clinical scales for children with CP and DD in order to assess patients' abilities during the assessments. The investigators also selected metrics obtained from end-point (hand) kinematic data, including movement speed and accuracy, in order to have quantitative measurements of patients' motor abilities.
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:
Children in the ISG-Group first participated in the VR-assisted rehabilitation, which consisted in 8 sessions with immersive virtual environment and wearable haptic devices, and were then crossed over and followed during an intended duration of 6 hours of conventional therapy.
Device: Serious Game · Other: Conventional Therapy
Children from DSG-Group were followed during an intended duration of 6 hours of conventional therapy before receiving VR-assisted rehabilitation with immersive virtual environment and wearable haptic devices.
Device: Serious Game · Other: Conventional Therapy
Serious Game (SG) refers to the use of immersive virtual environments and wearable haptic devices during the treatment. Two SG were specifically developed to allow a playful training of different, targeted Upper Limb (UL) movement based on typical rehabilitation exercises (reach-to-grasp, linear path tracking, hand orientation). The child interacts directly with a virtual environment through haptic feedback provided to his/her fingertips. In particular, "moneybox game" focused on pincer grasp and reaching tasks with pronation/supination od the hand while "marble labyrinth game" focused on pointing and tracking movements requiring both eye-hand and upper limb inter-joint coordination.
Conventional therapy (CONV) refers to the neurocognitive rehabilitation approach, with the purpose of improving pointing, tracking, reaching and grasping, and pronation/supination of the forearm. The therapeutic sessions were performed with the exception of the visual channel to ensure that the child focused his/her attention on tactile/kinesthetic information to complete the task. In particular, five different tasks have been proposed during the sessions: 1) recognize trajectories; 2) arm proprioception; 3) object manipulation; 4) recognize surfaces; 5) forearm orientation.
Change From Baseline in Time Scores on Nine Hole Peg Test (9-HPT) for both Dominant and Non-Dominant Hands at 4, 8, 16 and 24 weeks
Nine Hole Peg Test (9-HPT) is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The child is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the child picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded.
Time frame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Change From Baseline in Kinematic Metrics on Linear Path Tracking (LPT) and Reach-to-Grasp (RtG) Tasks for Dominant Hand at 4, 8, 16 and 24 weeks
The evaluation task consisted of two reach-to-grasp tasks requiring forearm pronation or supination and three linear path tracking (forward and sideways). For the RtG task, the child was asked to flip a card protruding from an horizontal support. For the LPT, the child was seated in front of a desk with the hand positioned, at rest, close to the body on the sagittal plane. Then a target was put on the desk (always at the same distance from the starting position) and the child was asked to reach the target by moving the hand along a straight path. All tasks were performed with the preferred arm at self selected speed. The investigators then extracted kinematic metrics (movement speed, accuracy and smoothness) from end-point (hand) kinematic data.
Time frame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Number of Participants with Treatment-Related Adverse Events according to the CTCAE v.4.0
The investigators referred to the following System Organ Class (SOC): Eye disorders, General disorders and administration site conditions, Nervous system disorders, Psychiatric disorders.
Time frame: Up to 16 weeks
Plan to share: Undecided
Ran from Feb 2017 to primary completion in Jun 2017, 3 months.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 3 months is below that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Scuola Superiore Sant'Anna di Pisa