An interventional study of Play Cluff Session in Upper Limb Disability, Upper Limb Dysfunction and Upper Limb Deficit, sponsored by IRCCS Eugenio Medea. Recruiting at 3 sites in Italy. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Treatment
Children with congenital or acquired neuromotor disorders may experience difficulties in upper-limb movement and function, which can affect their ability to perform everyday activities. Technology-assisted rehabilitation, including non-immersive virtual reality and exergames, may provide motivating and engaging opportunities to promote repeated, goal-directed upper-limb movements. The PlayCuff system combines a wearable sensorized wrist orthosis with a dedicated suite of exergames designed to support upper-limb rehabilitation through interactive motor tasks.
This multicenter, exploratory, prospective clinical investigation will evaluate the performance and safety of the pre-market PlayCuff system in children aged 4 to 8 years with upper-limb motor disabilities due to congenital or acquired brain injury. PlayCuff combines mild wrist stabilization with wireless motion sensing and gesture recognition, allowing children to interact with dedicated non-immersive virtual reality exergames through movements of the upper limb. The exergames are designed to promote different upper-limb movements and motor control strategies. The rehabilitation sessions also include task-oriented grasping and manipulation activities performed with concrete objects.
Twenty children will participate in the study. Each participant will undergo approximately 3.5 months of study participation, including baseline observation and the intervention period. The intervention will consist of 10 sessions of 45 minutes using the PlayCuff system. During the study, participants will continue their usual daily activities and any standard rehabilitation therapies they normally receive.
The primary objective is to evaluate changes in upper-limb motor function, with the Melbourne Assessment 2 (MA2) serving as the primary outcome measure, with particular reference to the Range subscale. Secondary objectives are to evaluate changes in functional ability in everyday activities using the ABILHAND-Kids questionnaire and to assess cognitive functions using the inhibition subtest of the NEPSY-II and the sustained attention subtest of the Leiter-3. The usability of the PlayCuff system will also be assessed using the System Usability Scale.
Assessments will be performed before the intervention, after the intervention, and at follow-up, with an additional baseline observation period before treatment. The study will investigate changes in clinical outcomes following the PlayCuff intervention in comparison with changes observed during the baseline observation period.
IRCCS Eugenio Medea is the lead sponsor of 109 studies on the registry; 52 are open to participants now.
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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.
This multicenter, exploratory, prospective study will evaluate a 5-week rehabilitation program using the PlayCuff system in children aged 4-8 years with upper-limb motor disability due to congenital or acquired brain injury. The intervention consists of 10 sessions (2/week, 45 minutes each) combining non-immersive virtual reality exergames with task-oriented grasping, manipulation and bimanual activities using concrete materials. Exercises target upper-limb motor control and are adapted to the child's abilities. Participants will be assessed at T-1 (5 weeks before treatment), T0 (before treatment), T1 (after treatment), and T2 (1-month follow-up). The primary outcome is the Melbourne Assessment 2 (MA2). Secondary outcomes include ABILHAND-Kids, the Leiter-3 sustained attention subtest, discrete performance variables recorded during exergames, and the System Usability Scale (SUS). T-1-T0 will assess baseline stability, T0-T1 treatment-related changes, and T1-T2 maintenance of effects.
Device: Play Cluff Session
The treatment will be performed at the clinical centers participating in the study and will consist of 10 rehabilitation sessions of approximately 45 minutes each, conducted twice weekly over approximately 5 weeks. Each session will combine 2-3 non-immersive virtual reality exergames using the PlayCuff software with task-oriented activities using concrete materials to support the functional transfer of the trained movements. Activities will target shoulder flexion, adduction and abduction, elbow flexion and extension, wrist flexion and extension, forearm pronation and supination, grasping, manipulation, and bimanual activities. Tasks will be adapted according to the child's MACS level, while maintaining the same functional task. Sessions will be monitored and delivered by rehabilitation staff, who will select and progressively adapt activities according to the child's characteristics and progress. Participants will continue their usual daily activities and standard therapies.
Change in MA2 Range subscale score- intervention
The Melbourne Assessment 2 (MA2) Range of Movement subscale assesses the quality of upper-limb movement. The raw subscale score ranges from 0 to 27, with higher scores indicating better movement quality. Change in the score from T0 (before treatment) to T1 (after completion of the PlayCuff rehabilitation program) will be measured.
Time frame: 5 weeks
Number of serious adverse events (SAEs) related or potentially related to the PlayCuff device
Number of serious adverse events occurring during the treatment and follow-up periods that are considered related or potentially related to use of the PlayCuff device.
Time frame: 9 weeks
Change in MA2 Accuracy, Dexterity, and Fluency subscale scores- intervention
Change in the Accuracy, Dexterity, and Fluency subscale scores of the Melbourne Assessment 2 (MA2). Each subscale is scored from 0 to 100, with higher scores indicating better upper limb function. Change from T0 to T1 will be measured.
Time frame: 5 weeks
Change in ABILHAND-Kids total score- intervention
Change in the total score and percentage score of the ABILHAND-Kids questionnaire, assessing the child's ability to perform everyday manual activities, particularly bimanual activities. The total score ranges from 0 to 42, with higher scores indicating better manual ability. The percentage score ranges from 0% to 100%, with higher percentages indicating better manual ability. Change from T0 to T1 will be measured.
Time frame: 5 weeks
Leiter-3 Sustained Attention- intervention
Change in sustained attention performance assessed using the Sustained Attention subtest of the Leiter-3. Performance will be evaluated based on the recorded raw and standardized scores and error measures. Higher total standard scores indicate better performance. Change from T0 to T1 will be measured.
Time frame: 5 weeks
Change in NEPSY-II Inhibition - Intervention
Change in performance on the Inhibition subtest of the NEPSY-II. Performance is evaluated using completion time, total errors, error percentiles, and standardized or combined scores, as applicable according to age and the study assessment procedures. Better performance is indicated by shorter completion times and fewer errors, with higher standardized scores indicate better performance. Change from T0 to T1 will be measured.
Time frame: 5 weeks
Change in MA2 Range subscale score- baseline
Changes in the Range subscale of the Melbourne Assessment 2 (MA2) assessed between T-1 (5 weeks before treatment) and T0 (before the start of PlayCuff rehabilitation) .
Time frame: 5 weeks
Change in MA2 Accuracy, Dexterity, and Fluency subscale scores- baseline
Changes in the Accuracy, Dexterity, and Fluency subscale scores of the Melbourne Assessment 2 (MA2), assessed between T-1 (5 weeks before treatment) and T0 (before the start of PlayCuff rehabilitation)
Time frame: 5 weeks
Change in ABILHAND-Kids total score- baseline
Change in the total score and percentage score of the ABILHAND-Kids questionnaire between T-1 and T0.
Time frame: 5 weeks
Leiter-3 Sustained Attention- baseline
Change in sustained attention performance assessed using the Sustained Attention subtest of the Leiter-3 between T-1 and T0.
Time frame: 5 weeks
Change in NEPSY-II Inhibition - baseline
Change in performance on the Inhibition subtest of the NEPSY-II between T-1 and T0.
Time frame: 5 weeks
System Usability Scale (SUS) score
Usability of the PlayCuff system assessed using the System Usability Scale (SUS), a 10-item questionnaire yielding a total score ranging from 0 to 100. Higher scores indicate better perceived usability of the system. The SUS will be administered at the end of the PlayCuff rehabilitation program (T1).
Time frame: After the treatment
Evaluation of children's exergame performance based on game scores and successful actions
Quantification and characterization of discrete variables recorded during the exergames, representing the child's ability to successfully complete the gaming activities during the whole treatment. The variables include the final score achieved in each game and, for each game, the number of successful actions out of the total number of actions performed. Descriptive statistics will be used to analyze these discrete data and evaluate changes over time in the children's gaming performance.
Time frame: After the treatment
Change in MA2 Range subscale score- Follow up
Change in the MA2 Range subscale score from T1 (at the end of the PlayCuff treatment) to T2 (Follow up) will be measured.
Time frame: 4 weeks
Change in MA2 Accuracy, Dexterity, and Fluency subscale scores- follow up
Changes in the Accuracy, Dexterity, and Fluency subscale scores of the Melbourne Assessment 2 (MA2), assessed between T1 (at the end of the rehabilitation program), and T2 (1 month after completion of treatment).
Time frame: 4 weeks
Change in ABILHAND-Kids total score- follow up
Changes in the total score and percentage score of the ABILHAND-Kids questionnaire between T1 and T2.
Time frame: 4 weeks
Leiter-3 Sustained Attention- follow up
Change in sustained attention performance assessed using the Sustained Attention subtest of the Leiter-3 between T1 and T2.
Time frame: 4 weeks
Change in NEPSY-II Inhibition - Follow up
Change in performance on the Inhibition subtest of the NEPSY-II between T1 and T2.
Time frame: 4 weeks
Plan to share: Undecided
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Start is estimated for Nov 2026; primary completion for Jul 2027, 7 months later.
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