NCT07694804

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 4, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Spastic diplegic cerebral palsyProprioceptive neuromuscular facilitationTask-oriented trainingMotor functionFunctional independence

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline, Week 3, and Week 6

  • 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.

    Baseline, Week 3, and Week 6

  • 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.

    Baseline, Week 3, and Week 6

Study Arms (3)

Proprioceptive Neuromuscular Facilitation (PNF)

EXPERIMENTAL

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.

Procedure: Proprioceptive Neuromuscular Facilitation (PNF)

Task-Oriented Training (TOT)

EXPERIMENTAL

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.

Procedure: Task-Oriented Training (TOT)

Combined PNF and Task-Oriented Training

EXPERIMENTAL

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.

Procedure: Combined Proprioceptive Neuromuscular Facilitation and Task-Oriented Training

Interventions

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.

Proprioceptive Neuromuscular Facilitation (PNF)

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.

Task-Oriented Training (TOT)

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.

Combined PNF and Task-Oriented Training

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand Institute of Rehabilitation

Mansehra, KPK, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr Zahid Mehmood

    Ibadat International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nauman Khan, Master

CONTACT

Dr Zahid Mehmood, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by an assessor who is blinded to participants' group allocation. Due to the nature of the physiotherapy interventions, participants and treating physiotherapists cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2026

First Posted

July 10, 2026

Study Start

February 17, 2026

Primary Completion

July 5, 2026

Study Completion

July 8, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations