PlayCuff: a Unilateral Device for Pediatric Upper Limb Rehabilitation
NCT07933289, Not applicable, Recruiting, IRCCS Eugenio Medea
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PlayCuff: a Unilateral Device for Pediatric Upper Limb Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT07933289 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | IRCCS Eugenio Medea | ClinicalTrials.gov |
| Conditions | Upper Limb Disability, Upper Limb Dysfunction, Upper Limb Deficit | ClinicalTrials.gov |
| Interventions | Play Cluff Session | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in MA2 Range subscale score- intervention | 5 weeks | 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. | ClinicalTrials.gov |
| Primary | Number of serious adverse events (SAEs) related or potentially related to the PlayCuff device | 9 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in MA2 Accuracy, Dexterity, and Fluency subscale scores- intervention | 5 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in ABILHAND-Kids total score- intervention | 5 weeks | 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. | ClinicalTrials.gov |
| Secondary | Leiter-3 Sustained Attention- intervention | 5 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in NEPSY-II Inhibition - Intervention | 5 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in MA2 Range subscale score- baseline | 5 weeks | 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) . | ClinicalTrials.gov |
| Secondary | Change in MA2 Accuracy, Dexterity, and Fluency subscale scores- baseline | 5 weeks | 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) | ClinicalTrials.gov |
| Secondary | Change in ABILHAND-Kids total score- baseline | 5 weeks | Change in the total score and percentage score of the ABILHAND-Kids questionnaire between T-1 and T0. | ClinicalTrials.gov |
| Secondary | Leiter-3 Sustained Attention- baseline | 5 weeks | Change in sustained attention performance assessed using the Sustained Attention subtest of the Leiter-3 between T-1 and T0. | ClinicalTrials.gov |
| Secondary | Change in NEPSY-II Inhibition - baseline | 5 weeks | Change in performance on the Inhibition subtest of the NEPSY-II between T-1 and T0. | ClinicalTrials.gov |
| Secondary | System Usability Scale (SUS) score | After the treatment | 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). | ClinicalTrials.gov |
| Secondary | Evaluation of children's exergame performance based on game scores and successful actions | After the treatment | 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. | ClinicalTrials.gov |
| Secondary | Change in MA2 Range subscale score- Follow up | 4 weeks | Change in the MA2 Range subscale score from T1 (at the end of the PlayCuff treatment) to T2 (Follow up) will be measured. | ClinicalTrials.gov |
| Secondary | Change in MA2 Accuracy, Dexterity, and Fluency subscale scores- follow up | 4 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change in ABILHAND-Kids total score- follow up | 4 weeks | Changes in the total score and percentage score of the ABILHAND-Kids questionnaire between T1 and T2. | ClinicalTrials.gov |
| Secondary | Leiter-3 Sustained Attention- follow up | 4 weeks | Change in sustained attention performance assessed using the Sustained Attention subtest of the Leiter-3 between T1 and T2. | ClinicalTrials.gov |
| Secondary | Change in NEPSY-II Inhibition - Follow up | 4 weeks | Change in performance on the Inhibition subtest of the NEPSY-II between T1 and T2. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)