- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr Zahid Mehmood, Master
- Phone Number: 03004615611
- Email: zahidmehmood8754@gmail.com
Study Contact Backup
- Name: Nauman Khan, Master
- Phone Number: +92 310 5062518
- Email: naumankhan5998@gmail.com
Study Locations
-
-
KPK
-
Mansehra, KPK, Pakistan
- Recruiting
- Helping Hand Institute of Rehabilitation
-
Contact:
- Dr. Pirzada Khattak HOD, PhD
- Phone Number: 0333-2284856
- Email: Pirzada.khattak@hhrd.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Function
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr Zahid Mehmood, Ibadat International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Damage, Chronic
- Cerebral Palsy
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Muscle Stretching Exercises
Other Study ID Numbers
- Ref: IIUI/RERC/ADT/2026/02/240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
University of LahoreUniversity of Lahore Hospital (ULH)CompletedCerebral Palsy (CP) | Diplegic Cerebral Palsy | Postural Stability | Upper Extremity Function | Diplegic Spastic Cerebral Palsy | Trunk MobilityPakistan
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
Clinical Trials on Proprioceptive Neuromuscular Facilitation (PNF)
-
University of Sao PauloUnknownAssessment of Muscle Force IrradiationBrazil
-
Medical University of LublinCompleted
-
Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Upper Extremity Dysfunction | Muscle Strength | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Upper Extremity FunctionsTurkey
-
Cairo UniversityRecruiting
-
Universidade Federal de PernambucoDaniella Araújo de Oliveira; Angélica da Silva TenórioCompletedOsteoarthritis KneeBrazil
-
University of GrazVU University of AmsterdamCompleted
-
Wafaa Mahmoud AminWithdrawnMotor ActivitySaudi Arabia
-
Riphah International UniversityRecruiting
-
Riphah International UniversityCompletedKnee OsteoarthritisPakistan
-
Uskudar UniversityCompletedAdhesive CapsulitisTurkey