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Cerebral PalsyPNF-TOT-CPNCT07694804

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

A study testing Proprioceptive Neuromuscular Facilitation (PNF), Task-Oriented Training (TOT) and Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented Training in people with Cerebral Palsy and Spastic Diplegia, run by Ibadat International University, Islamabad at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cerebral Palsy, Spastic Diplegia
What is being tested?
Proprioceptive Neuromuscular Facilitation (PNF), Task-Oriented Training (TOT) and Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented Training
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 sitePakistan
Study dates
17 Feb 2026to 8 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nauman Khan, Master contact

+92 310 5062518

naumankhan5998@gmail.com

Dr Zahid Mehmood, Master contact

03004615611

zahidmehmood8754@gmail.com

Pakistan1 site, 1 recruiting
  • Helping Hand Institute of Rehabilitation

    Mansehra, KPK

    Dr. Pirzada Khattak HOD, PhD, 0333-2284856, Pirzada.khattak@hhrd.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Proprioceptive Neuromuscular Facilitation (PNF), Task-Oriented Training (TOT), Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented Training
Keywords
Spastic diplegic cerebral palsy, Proprioceptive neuromuscular facilitation, Task-oriented training, Motor function, Functional independence
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proprioceptive Neuromuscular Facilitation (PNF)Procedure or surgery

    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.

  • Task-Oriented Training (TOT)Procedure or surgery

    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.

  • Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented TrainingProcedure or surgery

    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.

Study groups in NCT07694804
Study groupRoleWhat they receive
Proprioceptive Neuromuscular Facilitation (PNF)ExperimentalParticipants 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.
Receives: Procedure: Proprioceptive Neuromuscular Facilitation (PNF)
Task-Oriented Training (TOT)ExperimentalParticipants 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.
Receives: Procedure: Task-Oriented Training (TOT)
Combined PNF and Task-Oriented TrainingExperimentalParticipants 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.
Receives: Procedure: Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Upper Extremity Function

    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.

    Measured: Baseline, Week 3, and Week 6

  2. Functional Independence in Activities of Daily Living

    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.

    Measured: Baseline, Week 3, and Week 6

  3. Upper Extremity Range of Motion

    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.

    Measured: Baseline, Week 3, and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start17 Feb 2026
  3. Primary completion5 Jul 2026 (estimated)
  4. Study completion8 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of three parallel intervention groups: (1) Proprioceptive Neuromuscular Facilitation (PNF), (2) Task-Oriented Training (TOT), or (3) Combined PNF and TOT. Participants will remain in their assigned group throughout the 6-week intervention period, and outcomes will be compared between groups.3
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694804
Sponsor's protocol ID
Ref: IIUI/RERC/ADT/2026/02/240
Acronym
PNF-TOT-CP
Status last verified
Jul 2026
First submitted
4 Jul 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Proprioceptive Neuromuscular Facilitation (PNF), Task-Oriented Training (TOT) and Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented Training in people with Cerebral Palsy and Spastic Diplegia, run by Ibadat International University, Islamabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nauman Khan, Master (+92 310 5062518, naumankhan5998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Extremity Function (time frame: Baseline, Week 3, and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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