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Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy (PNF-TOT-CP)

4. Juli 2026 aktualisiert von: Ibadat International University, Islamabad

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

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

Interventionell

Einschreibung (Geschätzt)

63

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • KPK
      • Mansehra, KPK, Pakistan
        • Rekrutierung
        • Helping Hand Institute of Rehabilitation
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

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

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Upper Extremity Function
Zeitfenster: Baseline, Week 3, and Week 6
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
Functional Independence in Activities of Daily Living
Zeitfenster: Baseline, Week 3, and Week 6
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.
Baseline, Week 3, and Week 6
Upper Extremity Range of Motion
Zeitfenster: Baseline, Week 3, and Week 6
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.
Baseline, Week 3, and Week 6

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Dr Zahid Mehmood, Ibadat International University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Februar 2026

Primärer Abschluss (Geschätzt)

5. Juli 2026

Studienabschluss (Geschätzt)

8. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

4. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy, as the informed consent process did not include permission for public data sharing. De-identified aggregate study results will be published in peer-reviewed journals and presented at scientific conferences. Requests for additional information regarding the study methodology or summary findings may be considered by the principal investigator in accordance with institutional policies and ethical guidelines.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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