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Lo studio clinico NCT07253857 (HABIT-ILE) per Paralisi cerebrale, Paralisi cerebrale spastica è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy (HABIT-ILE) 42 Randomizzato Pediatrico
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La sperimentazione clinica NCT07253857 (HABIT-ILE) è uno studio interventistico per Paralisi cerebrale, Paralisi cerebrale spastica, attualmente in arruolamento. Avviato il 20 dicembre 2025, prevede di arruolare 42 partecipanti. Sotto la guida di Lahore University of Biological and Applied Sciences, dovrebbe concludersi entro il 1 maggio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 gennaio 2026.
Sommario breve
Cerebral palsy (CP), particularly the spastic diplegic subtype, is characterized by motor impairments such as spasticity and mobility limitations. In addition to motor dysfunction, children with CP often experience cognitive impairments affecting decision-making, problem-solving, working memory, selective attention, and inhibitory control. These non-motor challenges contribute to reduced social interaction and qualit...Mostra di più
Descrizione dettagliata
Cerebral palsy is a group of permanent movement and posture disorder caused by damage to the developing brain typically before, during or after birth. It is one of the most common neurodevelopmental disorder in childhood. Spasticity accounts for the majority of cases (around 92%), followed by dyskinesia, hypotonia, ataxia, and mixed types. Within spastic CP, three subtypes are recognized: diplegia, quadriplegia, and ...Mostra di più
Titolo ufficiale
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
Patologie
Paralisi cerebraleParalisi cerebrale spasticaPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- HABIT-ILE
- UBAS/ERB/FoRS/25/039 Aleena
Numero NCT
Data di inizio (effettiva)
2025-12-20
Ultimo aggiornamento pubblicato
2026-01-13
Data di completamento (stimata)
2026-05
Arruolamento (previsto)
42
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
HABIT-ILE
Intensive motor therapy
Cerebral Palsy
diplegic cerebral palsy with spasticity
Spastic cerebral palsy
Intensive motor therapy
Cerebral Palsy
diplegic cerebral palsy with spasticity
Spastic cerebral palsy
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleGROUP -A HABIT-ILE Therapy Name of intervention : Hand and Arm Bimanual Intensive Therapy Including Lower Extermity Type of intensity; intensive , activity based camp style rehabilitation program The HABIT-ILE therapy sessions will be structured to target both upper and lower limbs divided into three categories. Half of each session will focus on table-based bimanual tasks with postural challenges, performed while sitting on fitness balls or s...Mostra di più | GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity Hand Arm Bimanual Intensive Therapy Including Lower Extremity being a task based intensive therapy activities will be structured according to the participants ability to preform it. The intervention incorporates structured bimanual activities that progressively increase in motor complexity, along with functional tasks that necessitate coordinated use of both hands, systematically integrating postural and lower-extrem...Mostra di più |
SperimentaleGROUP- B Conventional Physical Therapy The intervention will be delivered five times per week, with each movement repeated three to five times. Sessions will begin at low to moderate intensity and will gradually progress based on patient response. Exercises will include weight-bearing activities such as sit-to-stand transitions to strengthen quadriceps and gluteal muscles, step initiation drills to activate tibialis anterior and gastrocnemius for proper f...Mostra di più | GROUP-B , Conventional Physical Therapy Conventional therapy will include stretches of lower extremity following bobath approach and cognitive exercises. |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Gross Motor Function Measure 88 (GMFM-88) | It is a standardized assessment tool designed to evaluate motor function in children with cerebral palsy (CP). It consists of 88 items that measure gross motor abilities across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking, running \& jumping. Each domain is scored on a 4-point ordinal scale where 0 indicates the child does not initiate the movement, 1 reflects initiation with less than 10% completion, 2 represents partial completion between 10% and less than 100%, and 3 denotes full completion of the movement as intended. Higher scores means that the child can move more independently while lower scores show difficulties in movement and point to areas where therapy is needed. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Behavior Rating Inventory Of Executive Function-2 (BRIEF-2) Parent form | It assesses executive function in children, including those with cerebral palsy (CP), measuring impulse control, emotional regulation, and working memory | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
ABILOCO-KIDS-CP | This assessment tool designed to evaluate locomotion ability in children with cerebral palsy | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
ABILHAND-KIDS-CP | it is an assessment tool designed to evaluate manual ability in children with cerebral palsy. It focuses on bimanual activities, measuring the child's ability to perform daily tasks requiring upper limb coordination. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Box and Block Test (BBT) | It is assessment tool for evaluating manual dexterity in individuals with cerebral palsy. It measures gross motor coordination of the upper limbs by assessing the ability to grasp, transport, and release small blocks within a timed period. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
6 Minute Walk Test | It evaluates how far a person can walk in six minutes | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino
Età minima
6 Years
Sessi idonei
Tutti
- Diagnosed with diplegic cerebral palsy
- CP children with manual ability level 1-3 on manual ability classification system
- Participants with gross motor function classification system level ranging from 1-3 will be included in the study.
- With an ability to grasp light objects and lift the more affected arm 15 cm above a table surface.
- Base line cognition level should be 20 or above assessed through mini mental state exam for children (MMC).
- Uncontrolled seizures
- Recent or planned botulinum toxin injections within 6 months
- Any recent orthopedic interventions that may affect motor function
- Visual impairments impeding with treatment protocol
Lahore University of Biological and Applied SciencesContatti principali dello studio
Contatto: Aleena Ishfaq, DPT, +92 3324210141, [email protected]
Contatto: Aruba Saeed, NMPT, PhD*, +92 3344399403, [email protected]
1 Centri dello studio in 1 paesi
Punjab Province
Pakistan Society for Rehabilitation of Differently Abled (PSRD), Lahore, Punjab Province, 54660, Pakistan
In arruolamento