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Neural Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy

A legfontosabb adatok

Ki végzi
IRCCS Fondazione Stella Maris
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
80 fő, tervezett
Kezdés
2026. jan.
Várható befejezés
2027. júl.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A regiszteradat frissítve
2026. január 27.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for children aged 5 to 15 with unilateral cerebral palsy (movement problems mainly on one side of the body). It is also looking for typically developing children of similar age as a comparison group.

Életkor
5 to 15 years
Nem
All sexes
A betegség stádiuma
Children with cerebral palsy: confirmed unilateral cerebral palsy, with hand use levels I to III on the Manual Ability Classification System (MACS). Comparison children: typical development and no documented clinically relevant disorders.
Korábbi kezelés
Children with cerebral palsy cannot join if they had arm or hand surgery in the 12 months before the study, or botulinum toxin injection in the 6 months before.

A részvétel fő kizáró okai

  • Severe arm or hand impairment (MACS level IV or higher, unable to grasp)
  • Arm or hand surgery within 12 months, or botulinum toxin injection within 6 months, before the study
  • Severe other illnesses
  • Severe cognitive disability, assessed with the WPPSI-IV, WISC-IV or WISC-V scales

A regiszter feltételei, szó szerint

Mind a 10 feltétel megnézéseKevesebb

Ki vehet részt

  • Children with confirmed diagnosis of Unilateral Cerebral Palsy,
  • Manual ability levels from I to III in the Manual Ability Classification System (MACS)
  • Children's age from 5 to 15 years old
  • 5 to 15 year-old children with typical development,
  • No documented clinically relevant disorders

Ki nem vehet részt

  • UpL surgery within 12 months prior to study entry and botulinum toxin injection within 6 months prior to study entry,
  • Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp),
  • Severe comobordities,
  • Severe cognitive disability, clinically assessed by the cognitive scales Wechsler, Preschool and Primary Scale of Intelligence (WPPSI-IV) or Wechsler Intelligence Scale for Children (WISC-IV or V); Typically Developing children:

Egyéb feltételek

  • Children with Unilateral Cerebral Palsy

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 5 és 15 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Cerebral palsy (CP) is the most common childhood-onset motor disorder, with Unilateral Cerebral Palsy (UCP)- motor impairment predominantly impacting one side of the body-representing the most frequent form of CP. Among available rehabilitation programs, Action Observation Treatment (AOT) has gained increasing attention for its demonstrated effectiveness in improving manual motor function. AOT involves the systematic observation of goal-directed actions followed by their execution/imitation and is thought to leverage the mirror mechanism and its role in motor learning. Specifically, it relies on the neurophysiological principle that observing others' actions activates the same neural structures involved in executing those actions, reflecting the engagement of the mirror neuron system (MNS). In children with CP, the feasibility and effectiveness of AOT have been shown functionally (Sgandurra et al., 2013, Buchignani et al., 2019). However, despite its theoretical grounding in MNS functioning, the neurophysiological correlates of this system in children with CP remain less characterized, with only limited investigations using functional neuroimaging (e.g., Sgandurra et al., 2020) or neurophysiological methods such as electroencephalography (EEG; e.g., Demas et al., 2019).

A teljes eredeti leírásKevesebb

This observational study aims to characterize the neurophysiological signatures of action execution and action observation in children aged 5-15 years with a diagnosis of UCP compared to a group of age-matched typically developing (TD) peers. To this end, non-invasive high-density EEG (hdEEG) will be used to quantify sensorimotor cortex modulation through mu-rhythm reactivity-specifically event-related desynchronization (ERD) and synchronization (ERS)-and its topographical distribution during an active visuo-motor task involving upper limbs. Mu-rhythm desynchronization (or suppression) over sensorimotor regions is a well-established marker of MNS engagement. A secondary objective is to examine the relationship between EEG measures and participants' attention, upper-limb kinematics, and manual motor function. To this purpose, participants will wear non-invasive wearable sensors to capture arm/hand kinematics, and attention will be monitored with a non-invasive eye-tracking system. Validated scales will be used to assess manual motor function.

Participants will take part in one single visit of about 1.5 hours. During the EEG acquisition session, children will wear a 128-channel EEG net and complete an active visuo-motor paradigm including the observation and execution of unimanual and bimanual goal-directed actions (e.g., reaching-grasping). In the observation condition, children will watch videos depicting these actions on a computer screen while refraining from movement. In the subsequent execution condition, they will interact themselves with the same objects as in the observation condition. Throughout the same session, children's attention/gaze will be tracked via eye-tracking, and upper-limb kinematics will be recorded using wearable inertial measurement unit (IMU) sensors. Before or after EEG acquisition, manual motor function will be assessed using two standardized scales: the Assisting Hand Assessment (AHA) and the Melbourne Assessment-2 (MA-2).

Data analysis will characterize the mu rhythm ERD topography and temporal dynamics during both action execution and action observation, within and between groups. Correlation analyses will explore associations between neurophysiological measures, gaze and attentional patterns, kinematic data, and motor assessments scores to elucidate how motor and attentional factors modulate sensorimotor cortical activation.

A vizsgálat 2 csoportja

  • Study Group

    40 children with Unilateral Cerebral Palsy (UCP), aged 5-15 years

  • Control Group

    40 typically developing (TD) children, aged 5-15 years

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Neurophysiological, Kinematics and Functional Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT07369167: ki vehet részt
A regiszteradat frissítve
2026. január 27.