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Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy (UL/SMC/ADL/CP)

3 novembre 2026 aggiornato da: Rabab Ragab Ahmed Barkat, Cairo University

Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Trial

The purposes of the current study will be to assess the effect of robotic gloves training on upper limb coordination, selective motor control (Wrist Extension/Flexion, Finger Flexion/Extension, Thumb Opposition (tip to tip pincer), Thumb extension (key grip) and activities of daily living in children with hemiparetic cerebral palsy.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Cerebral palsy (CP) is a group of conditions that affect movement and posture. It's caused by damage that occurs to the developing brain, most often before birth.

Etiological aspects of CP can be defined as prenatal etiology in 22% of the cases, probable perinatal etiology in 40% and undefined etiology in 38% of the cases.

Children with CP commonly have impairment of upper limb function, with various studies reporting a prevalence ranging from 57 to 83%.

Cerebral palsy (CP) also limits the International Classification of Functioning, Disability and Health (ICF) domain of activities, which refers to the ability to execute an essential task or action of daily living (e.g., eating, drinking, grooming, or dressing).

Hemiparetic CP is a form of CP in which one arm and leg on either the right or left side of the body is affected. Hemiparetic CP is the most common CP syndrome in children born at term.

Children with hemiparetic CP have unilateral prehensile dysfunction as a consequence of lesions in the sensorimotor cortex and corticospinal tract. Children whose hemiparesis involves the upper limb to a greater extent than the lower (arm-dominant hemiparesis) are much more likely to experience learning difficulties than those whose clinical pattern is leg-dominant.

Upper limb coordination is crucial for hand functional manual abilities and plays a vital role in functional independence and overall quality of life. Therefore, targeting upper limb coordination approaches with older children with CP is essential for maintaining or improving their performance.

Selective motor control is defined as isolated muscle activation during a voluntary posture or movement in a selected motion pattern. Therefore, SMC should be considered during evaluation and rehabilitation of affected UEF in children with spastic CP. However, there are not enough studies in the literature.

Children with unilateral spastic CP seldom use their paretic hand spontaneously in daily activities.

Children with hemiplegia often display difficulties in mobility and sensory functioning. These difficulties affect their activities in daily living and thus have a negative impact on the quality of their life.

Robotic gloves are more compact forms than exoskeleton devices. The structure of robotic devices is similar to a glove and envelops the paretic hand. The glove-like nature of these devices gives them intuitive functionality and can reduce stresses on the hand joints.

A direct benefit of assistive robotic gloves has been demonstrated over recent years on strength and functional ability in multiple studies with spinal cord injury (SCI) patients, stroke patients, and children with neurological hand limitations and elderly with age-related hand limitations.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Cairo, Egitto
        • Outpatient Clinic of Faculty of Physical Therapy, Cairo University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 8 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria

  • Diagnosis of unilateral spastic cerebral palsy (hemiparetic CP).
  • Age ranging from [e.g., 6 to 8] years old.
  • Level I, II on the Gross Motor Function Classification System (GMFCS).
  • Level II, III on the Manual Ability Classification System (MACS).
  • Sufficient cognitive ability and cooperation to understand instructions and follow verbal commands during training sessions.
  • Mild to moderate spasticity in the affected upper limb, scoring [e.g., ≤ 2] on the Modified Ashworth Scale (MAS).
  • Passive range of motion of the affected wrist and fingers adequate to fit comfortably inside and be assisted by the robotic glove device.
  • Legal guardians/parents willing and able to provide written informed consent, and child assent obtained where applicable.

Exclusion Criteria

  • Severe upper limb fixed contractures or structural joint deformities that prevent proper fitting or passive movement of the robotic glove.
  • Severe spasticity or rigid hypertonia scoring [e.g., > 2] on the Modified Ashworth Scale (MAS) in the target upper extremity.
  • Recent orthopedic surgery or botulinum toxin (Botox) injections in the affected upper limb within the past [e.g., 3 to 6] months.
  • Co-existing severe visual, hearing, or sensory impairments that significantly impede the ability to interact with the device or interactive gaming interfaces.
  • Uncontrolled epilepsy or history of severe, frequent seizures triggered by visual stimuli or active exertion.
  • Severe cognitive, behavioral, or psychological disorders that prevent compliance with the therapeutic protocol.
  • Simultaneous participation in another active upper limb rehabilitation clinical trial or intensive therapeutic protocol.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Robotic Glove Therapy

"Children with hemiplegic cerebral palsy in this group will perform structured upper limb coordination, selective motor control, and activities of daily living (ADL) training while wearing a robotic glove. The intervention utilizes the device's individual finger control capabilities to facilitate independent finger movement and targeted manual dexterity exercises."

"A rehabilitation program using a high-tech robotic glove that features individual finger control to allow independent finger movement. Participants will use the device to perform repetitive task-specific training, upper limb coordination drills, and activities of daily living (ADL) exercises designed to improve hemiparetic hand functionality and selective motor control."

Comparatore attivo: Conventional Occupational Therapy

"Children with hemiplegic cerebral palsy in this group will receive standard, conventional occupational therapy sessions. The intervention focuses on identical upper limb coordination exercises, selective motor control training, and functional activities of daily living (ADL) training using traditional manual techniques without the assistance of a robotic device."

"A traditional rehabilitation program focused on upper limb mobilization, functional manual dexterity training, and activities of daily living (ADL) tasks. Exercises are performed using standard clinical therapeutic equipment and manual therapist facilitation without any robotic device assistance."

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) - Upper Limb Coordination Subtest
Lasso di tempo: Baseline (Week 0) and post-intervention (Week 12)

The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Upper Limb Coordination Subtest is a standardized, norm-referenced measure designed to evaluate precise arm and hand movements, visual-tracking, and object manipulation. It consists of 7 items. The raw scores are converted into point scores, which are then translated into a standard subtest score. The minimum score is 1 and the maximum score is 30. Higher scores mean a better outcome, indicating superior upper limb coordination and manual proficiency.

Baseline (Week 0) and post-intervention (Week 12)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Test of Selective Control (TASC) Score
Lasso di tempo: Baseline (Week 0) and post-intervention (Week 12)

The Test of Selective Control (TASC) is a clinical assessment tool used to quantify selective motor control in the upper limbs of children with cerebral palsy. It evaluates the child's ability to isolate movements at specific joint levels (including the shoulder, elbow, forearm, wrist, and fingers) without involuntary trunk movement or mirror movements on the opposite side. Each joint movement is graded on a scale from 0 to 2. The total score is calculated by summing the joint scores, where the minimum score is 0 and the maximum score is 28. Higher scores mean a better outcome, indicating superior and more isolated selective motor control.

Baseline (Week 0) and post-intervention (Week 12)
Functional Independence Measure for Children (WeeFIM) - Self-Care Domain
Lasso di tempo: Baseline (Week 0) and post-intervention (Week 12)

The Functional Independence Measure for Children (WeeFIM) Self-Care domain is a standardized, discipline-free assessment tool used to evaluate functional independence and the burden of care in children with neurodevelopmental disabilities. The Self-Care domain consists of 8 items, including eating, grooming, bathing, upper body dressing, lower body dressing, toileting, bladder management, and bowel management. Each item is scored on a 7-point ordinal scale ranging from 1 (total assistance) to 7 (complete independence). For this specific domain, the minimum score is 8 and the maximum score is 56. Higher scores mean a better outcome, indicating greater functional independence in activities of daily living and less reliance on caregiver assistance.

Baseline (Week 0) and post-intervention (Week 12)

Collaboratori e investigatori

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Sponsor

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

25 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 ottobre 2026

Primo Inserito (Effettivo)

30 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • P.T.REC/012/006155

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .