- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Dr Zahid Mehmood, Master
- Telefonnummer: 03004615611
- E-Mail: zahidmehmood8754@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Nauman Khan, Master
- Telefonnummer: +92 310 5062518
- E-Mail: naumankhan5998@gmail.com
Studienorte
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KPK
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Mansehra, KPK, Pakistan
- Rekrutierung
- Helping Hand Institute of Rehabilitation
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Kontakt:
- Dr. Pirzada Khattak HOD, PhD
- Telefonnummer: 0333-2284856
- E-Mail: Pirzada.khattak@hhrd.pk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Upper Extremity Function
Zeitfenster: 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.
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Baseline, Week 3, and Week 6
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Functional Independence in Activities of Daily Living
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Dr Zahid Mehmood, Ibadat International University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Hirnschaden, chronisch
- Zerebralparese
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Therapeutika
- Physiotherapiemodalitäten
- Patientenversorgung
- Trainingstherapie
- Rehabilitation
- Nachbehandlung
- Kontinuität der Patientenversorgung
- Übung
- Muskeldehnungsübungen
Andere Studien-ID-Nummern
- Ref: IIUI/RERC/ADT/2026/02/240
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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