- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07827365
VR Versus Task-Oriented Circuit Training on UL Sensorimotor in Children With Immature Brain Injury
Effect of Virtual Reality Versus Task-Oriented Circuit Training on Upper Limb Sensorimotor Function in Children With Immature Brain Injury :Randomized Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life
Hypothesis
This study hypothesized that:
there is no difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with spastic cerebral palsy.
RESEARCH QUESTION:
Is there difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with immature brain injury?
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lama Saad El-Din SED Mahmoud
- Numer telefonu: 01157592636
- E-mail: lamaelsedawyy@hotmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Lama Saad El-Din SED Mahmoud
- Numer telefonu: 00201157592636
- E-mail: lamaelsedawyy@hotmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Forty four children with cerebral palsy,
- Age will range as (12:18) years old
- spastic cerebral palsy
- Gross motor function classification system: level I&II
- level I-III on the Manual Ability Classification System (MACS)
Exclusion Criteria:
- difficulty to communicate or to understand program instructions
- surgery/Botox injection during the last 6 months in the upper extremity
- uncontrolled severe seizures
- fixed deformities in the affected side;
- Attention deficit/hyperactivity disorders.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Virtual reality (VR)
Virtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function.
Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb.
The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning.
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Virtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function.
Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb.
The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning.
Inne nazwy:
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Eksperymentalny: Task-oriented circuit training
Task-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities.
Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects.
The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill.
Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability.
Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation.
|
Task-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities.
Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects.
The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill.
Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability.
Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pinch dynamometer
Ramy czasowe: three months
|
Pinch strength will be assessed using a pinch dynamometer to quantify the maximal voluntary pinch force of the affected hand.
The dynamometer will be positioned between the thumb and the specified finger(s), and participants will be instructed to apply maximal pinch force for approximately 3-5 seconds.
Three trials will be performed with adequate rest between trials, and the highest recorded value or mean of the three trials will be used for analysis.
|
three months
|
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fugl myer assessment for sensorimotor function of upper limb
Ramy czasowe: three months
|
The Fugl-Meyer Assessment (FMA) will be used to evaluate sensorimotor function of the upper extremity.
The upper-extremity section of the FMA will assess motor function, reflex activity, coordination, and speed of movement.
The assessment will include movements of the shoulder, elbow, forearm, wrist, and hand, with each item scored according to the standardized FMA scoring system.
Higher scores will indicate better sensorimotor performance of the affected upper extremity
|
three months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pediatric Quality of Life Inventory CP Module
Ramy czasowe: three months
|
The Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module) will be used to assess health-related quality of life in children with cerebral palsy.
The questionnaire will evaluate the child's perceived difficulties and limitations across cerebral palsy-specific domains, including daily activities, movement and balance, pain and hurt, fatigue, eating activities, and communication, as applicable to the child's age and functional level.
Items will be scored according to the standardized PedsQL CP Module scoring system, with higher scores indicating better health-related quality of life.
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three months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/006486
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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