- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07694804
Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy (PNF-TOT-CP)
ISOLATED VERSUS COMBINED EFFECTS OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION AND TASK-ORIENTED TRAINING ON UPPER EXTREMITY FUNCTION IN CHILDREN WITH SPASTIC DIPLEGIC CEREBRAL PALSY
Children with spastic diplegic cerebral palsy often experience upper extremity impairments, including reduced coordination, muscle control, and functional hand use, which limit independence in daily activities. Proprioceptive Neuromuscular Facilitation (PNF) and Task-Oriented Training (TOT) are commonly used rehabilitation approaches to improve motor function; however, evidence comparing their individual and combined effects on upper extremity function remains limited.
This randomized controlled trial aims to compare the effects of PNF alone, TOT alone, and a combined PNF plus TOT intervention on upper extremity function in children with spastic diplegic cerebral palsy. Sixty-three children aged 6 to 12 years with Gross Motor Function Classification System (GMFCS) levels I to III will be randomly assigned to one of three intervention groups. Each group will receive supervised 45-minute treatment sessions, three times per week for six weeks.
Upper extremity function, functional independence, and joint range of motion will be assessed at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks) using the Melbourne Assessment of Unilateral Upper Limb Function (MA2), Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS), and goniometric measurements. The findings of this study are expected to provide evidence regarding the most effective rehabilitation approach for improving upper extremity function in children with spastic diplegic cerebral palsy.
Přehled studie
Postavení
Podmínky
Detailní popis
Cerebral palsy (CP) is the most common cause of childhood physical disability and is characterized by permanent disorders of movement and posture resulting from non-progressive injury to the developing brain. Although children with spastic diplegic CP primarily present with lower-limb involvement, many also experience impaired upper extremity function, including reduced muscle coordination, impaired selective motor control, weakness, and limitations in reaching, grasping, and object manipulation. These impairments restrict participation in self-care, education, play, and other daily activities.
Task-Oriented Training (TOT) is an evidence-based rehabilitation approach that emphasizes repetitive practice of meaningful, goal-directed functional activities to promote motor learning and improve participation. Proprioceptive Neuromuscular Facilitation (PNF) is another therapeutic approach that enhances neuromuscular activation, proprioceptive input, and coordinated movement patterns through specific diagonal movement techniques. While both interventions have demonstrated beneficial effects in children with cerebral palsy, limited evidence directly compares their isolated and combined effects on upper extremity function in children with spastic diplegic CP.
This study is a three-arm randomized controlled trial designed to compare the effectiveness of PNF alone, TOT alone, and combined PNF plus TOT. A total of 63 children aged 6-12 years with spastic diplegic cerebral palsy (GMFCS levels I-III) will be recruited and randomly allocated to one of the three intervention groups using block randomization.
Participants will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks. The PNF group will perform upper extremity D1 and D2 diagonal movement patterns. The TOT group will perform structured functional activities including reaching, grasping, releasing, stacking, and object manipulation. The combined intervention group will receive both PNF and TOT within the same treatment session.
Outcome measures will include:
Melbourne Assessment of Unilateral Upper Limb Function (MA2) to assess upper limb movement quality.
Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS) to evaluate functional independence in self-care.
Goniometric measurements of shoulder, elbow, and wrist range of motion.
Assessments will be performed at baseline, three weeks, and six weeks by trained assessors. Statistical analyses will compare changes within and between groups to determine whether combined therapy provides greater improvements than either intervention alone.
The results of this trial are expected to strengthen the evidence base for pediatric neurorehabilitation and assist clinicians in selecting the most effective physiotherapy approach to improve upper extremity function and functional independence in children with spastic diplegic cerebral palsy.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dr Zahid Mehmood, Master
- Telefonní číslo: 03004615611
- E-mail: zahidmehmood8754@gmail.com
Studijní záloha kontaktů
- Jméno: Nauman Khan, Master
- Telefonní číslo: +92 310 5062518
- E-mail: naumankhan5998@gmail.com
Studijní místa
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KPK
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Mansehra, KPK, Pákistán
- Nábor
- Helping Hand Institute of Rehabilitation
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Kontakt:
- Dr. Pirzada Khattak HOD, PhD
- Telefonní číslo: 0333-2284856
- E-mail: Pirzada.khattak@hhrd.pk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Children aged 6 to 12 years. Clinical diagnosis of spastic diplegic cerebral palsy. Gross Motor Function Classification System (GMFCS) Levels I-III. Ability to understand and follow simple verbal instructions. Medically stable and able to participate in physiotherapy sessions. Parent or legal guardian willing to provide written informed consent.
Exclusion Criteria:
Orthopedic surgery involving the upper or lower extremities within the previous 6 months.
Botulinum toxin injections administered within the previous 6 months. Severe visual, hearing, or cognitive impairments that would interfere with assessment or treatment.
Uncontrolled epilepsy or other unstable neurological or medical conditions. Fixed upper extremity contractures or musculoskeletal deformities preventing participation in the intervention.
Participation in another structured upper extremity rehabilitation program during the study period.
Failure to obtain informed consent from a parent or legal guardian.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Proprioceptive Neuromuscular Facilitation (PNF)
Participants assigned to this arm will receive Proprioceptive Neuromuscular Facilitation (PNF) exercises targeting the upper extremity.
Treatment will include upper limb diagonal movement patterns (D1 and D2 flexion and extension) to improve neuromuscular control, coordination, muscle activation, and functional movement.
Each participant will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks.
|
Participants will receive Proprioceptive Neuromuscular Facilitation (PNF) exercises for the upper extremity using diagonal movement patterns (D1 and D2 flexion and extension).
Treatment is designed to facilitate neuromuscular activation, improve muscle strength, coordination, proprioception, and functional upper limb movement.
Each participant will receive supervised 45-minute treatment sessions, three times per week for six weeks.
Participants will perform structured, goal-directed functional upper extremity activities including reaching, grasping, releasing, object manipulation, stacking, and other task-specific exercises.
The intervention emphasizes repetitive practice of meaningful functional tasks to improve motor control, upper limb function, and independence in daily activities.
Sessions will last 45 minutes, three times per week for six weeks.
Participants will receive a combined intervention consisting of Proprioceptive Neuromuscular Facilitation (PNF) followed by Task-Oriented Training (TOT) within the same treatment session.
The intervention integrates upper extremity PNF diagonal movement patterns with repetitive task-specific functional activities to enhance neuromuscular control, motor learning, upper limb function, and functional independence.
Each supervised session will last 45 minutes and will be delivered three times per week for six weeks.
|
|
Experimentální: Task-Oriented Training (TOT)
Participants assigned to this arm will receive Task-Oriented Training focused on repetitive, goal-directed functional activities of the upper extremity.
Intervention will include reaching, grasping, releasing, object manipulation, stacking, and other task-specific activities designed to improve upper limb function and functional independence.
Each participant will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks.
|
Participants will receive Proprioceptive Neuromuscular Facilitation (PNF) exercises for the upper extremity using diagonal movement patterns (D1 and D2 flexion and extension).
Treatment is designed to facilitate neuromuscular activation, improve muscle strength, coordination, proprioception, and functional upper limb movement.
Each participant will receive supervised 45-minute treatment sessions, three times per week for six weeks.
Participants will perform structured, goal-directed functional upper extremity activities including reaching, grasping, releasing, object manipulation, stacking, and other task-specific exercises.
The intervention emphasizes repetitive practice of meaningful functional tasks to improve motor control, upper limb function, and independence in daily activities.
Sessions will last 45 minutes, three times per week for six weeks.
Participants will receive a combined intervention consisting of Proprioceptive Neuromuscular Facilitation (PNF) followed by Task-Oriented Training (TOT) within the same treatment session.
The intervention integrates upper extremity PNF diagonal movement patterns with repetitive task-specific functional activities to enhance neuromuscular control, motor learning, upper limb function, and functional independence.
Each supervised session will last 45 minutes and will be delivered three times per week for six weeks.
|
|
Experimentální: Combined PNF and Task-Oriented Training
Participants assigned to this arm will receive a combination of Proprioceptive Neuromuscular Facilitation (PNF) and Task-Oriented Training (TOT) during each treatment session.
The intervention will incorporate upper extremity PNF diagonal movement patterns followed by task-specific functional training, including reaching, grasping, releasing, and object manipulation.
Each participant will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks.
|
Participants will receive Proprioceptive Neuromuscular Facilitation (PNF) exercises for the upper extremity using diagonal movement patterns (D1 and D2 flexion and extension).
Treatment is designed to facilitate neuromuscular activation, improve muscle strength, coordination, proprioception, and functional upper limb movement.
Each participant will receive supervised 45-minute treatment sessions, three times per week for six weeks.
Participants will perform structured, goal-directed functional upper extremity activities including reaching, grasping, releasing, object manipulation, stacking, and other task-specific exercises.
The intervention emphasizes repetitive practice of meaningful functional tasks to improve motor control, upper limb function, and independence in daily activities.
Sessions will last 45 minutes, three times per week for six weeks.
Participants will receive a combined intervention consisting of Proprioceptive Neuromuscular Facilitation (PNF) followed by Task-Oriented Training (TOT) within the same treatment session.
The intervention integrates upper extremity PNF diagonal movement patterns with repetitive task-specific functional activities to enhance neuromuscular control, motor learning, upper limb function, and functional independence.
Each supervised session will last 45 minutes and will be delivered three times per week for six weeks.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Upper Extremity Function
Časové okno: Baseline, Week 3, and Week 6
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Upper extremity function will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function, Second Edition (MA2).
The MA2 evaluates movement quality, dexterity, accuracy, fluency, and range of motion during functional upper limb tasks.
Higher scores indicate better upper extremity function.
|
Baseline, Week 3, and Week 6
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Functional Independence in Activities of Daily Living
Časové okno: Baseline, Week 3, and Week 6
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Functional independence will be assessed using the Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS).
The instrument measures the child's capability to perform age-appropriate self-care and functional activities.
Higher scores indicate greater functional independence.
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Baseline, Week 3, and Week 6
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Upper Extremity Range of Motion
Časové okno: Baseline, Week 3, and Week 6
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Active range of motion of the shoulder, elbow, and wrist joints will be measured using a standard universal goniometer.
Measurements will be recorded in degrees to evaluate changes in joint mobility following the intervention.
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Baseline, Week 3, and Week 6
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Dr Zahid Mehmood, Ibadat International University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Poškození mozku, chronické
- Dětská mozková obrna
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Terapeutika
- Modality fyzikální terapie
- Péče o pacienty
- Cvičební terapie
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Cvičení
- Cvičení protahování svalů
Další identifikační čísla studie
- Ref: IIUI/RERC/ADT/2026/02/240
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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