NCT07116798

Brief Summary

This study aims to compare the effects of two different upper extremity strengthening exercise approaches-bilateral strengthening exercises based on Proprioceptive Neuromuscular Facilitation (PNF) patterns and plyometric exercises-on muscle thickness, joint range of motion, muscle strength, and functional performance in children with unilateral spastic cerebral palsy (USCP). Although strengthening exercises targeting the affected upper limb in children with USCP have been investigated in numerous studies, to our knowledge, no previous research has directly compared the effects of bilateral PNF-based strengthening exercises and plyometric training. Incorporating PNF patterns into upper extremity rehabilitation programs has been previously recommended, and examining the efficacy of these exercises in comparison with plyometric training may contribute valuable insights to the literature and inform clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

August 7, 2025

Last Update Submit

April 2, 2026

Conditions

Keywords

cerebral palsyupper extremitystrengthening

Outcome Measures

Primary Outcomes (3)

  • Muscle Thickness Measurement by Ultrasonography

    Ultrasonographic measurements will be performed using the Esaote Mylab 60 device with a linear probe. Muscle thickness will be assessed in the upper trapezius, rhomboid major, anterior deltoid, lateral triceps brachii, long head of biceps brachii, extensor carpi radialis brevis, extensor digitorum communis, and flexor digitorum superficialis. Measurements will be taken with the elbow flexed at 70°, in standardized resting positions, with forearm in pronation or supination depending on the muscle group. To ensure reliability, three separate images per muscle will be taken, with the probe repositioned each time. Anatomical landmarks will be palpated and marked. Muscle thickness will be measured as the distance between the subcutaneous fat-muscle and muscle-bone interfaces.

    Baseline and after 8-weeks

  • Range of Motion Assessment

    Joint range of motion (ROM) will be assessed before and after treatment using a universal goniometer. Active ROM measurements will include shoulder flexion and abduction (measured in standing), elbow flexion and extension (in supine), and forearm pronation-supination and wrist flexion-extension (in sitting). Movements will first be demonstrated on the unaffected limb, then performed with the affected limb. Active ROM values will be recorded. Each movement will be measured three times, and the mean value in degrees will be documented. Measurements will follow Kendall-McCreary criteria to ensure standardization and accuracy.

    Baseline and after 8-weeks

  • Muscle Strength Assessment

    Muscle strength of shoulder flexion-abduction, elbow flexion-extension, forearm pronation-supination, and wrist flexion-extension will be assessed before and after treatment using a hand-held dynamometer (HOGGAN microFET2). A towel will be placed between the limb and device to ensure full contact and minimize sensitivity caused by surface hardness. The "make method," accepted for pediatric use, will be applied: the physiotherapist will ask the child to push maximally against the fixed device. The test will first be demonstrated on the unaffected limb. Two practice trials will be conducted on the affected side to ensure comprehension, followed by three test measurements. A rest interval will be given between trials. The mean of the three tests will be recorded in kilograms (kg).

    Baseline and after 8-weeks

Secondary Outcomes (2)

  • Quality of Upper Extremity Skills Test-QUEST

    Baseline and after 8-weeks

  • ABILHAND- Kids

    Baseline and after 8-weeks

Study Arms (2)

PNF Group (Strengthening Based on Proprioceptive Neuromuscular Facilitation Patterns)

EXPERIMENTAL

The shoulder and scapular patterns listed below will first be taught to the child using the rhythmic initiation technique. Following instruction, the child will be asked to perform the patterns actively without resistance. Shoulder flexion - adduction - external rotation and shoulder extension - abduction - internal rotation (with the elbow extended) Shoulder extension - adduction - internal rotation and shoulder flexion - abduction - external rotation (with the elbow extended) In addition to the shoulder patterns, scapular patterns including anterior depression - posterior elevation and anterior elevation - posterior depression will also be performed with the same progression.

Other: Exercise

Plyometric Group (Plyometric Exercises)

EXPERIMENTAL

Participants in the plyometric group will perform upper extremity plyometric exercises aimed at improving muscular power, neuromuscular control, and functional performance. The exercises will be selected to provide dynamic resistance and emphasize rapid stretch-shortening cycle movements of the upper limb. Training will be conducted using elastic bands, medicine balls, and body weight as appropriate to the child's developmental level and physical capacity. The exercise program will include progressive variations in terms of intensity, volume (sets and repetitions), and complexity over the intervention period, as detailed in the progression table. Rest intervals of no more than one minute will be allowed between sets. All exercises will be performed bilaterally and under the supervision of a physiotherapist to ensure proper technique and safety.

Other: Exercise

Interventions

Strengthening Exercises Based on Proprioceptive Neuromuscular Facilitation Patterns

PNF Group (Strengthening Based on Proprioceptive Neuromuscular Facilitation Patterns)

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 5 and 12 years
  • Diagnosed with unilateral spastic type cerebral palsy
  • Classified as Level I or II according to the Gross Motor Function Classification System (GMFCS)
  • Classified as Level I or II according to the Manual Ability Classification System (MACS)
  • Upper extremity muscle tone ≤2 on the Modified Ashworth Scale
  • Willing to suspend other upper extremity therapeutic interventions during the study period
  • Able to cooperate and follow instructions provided by the researcher
  • Voluntarily willing to participate in the study

You may not qualify if:

  • History of any upper extremity surgery or Botulinum toxin (Btx) injection within the past 6 months
  • Presence of an additional neurological disorder other than cerebral palsy
  • Having visual and/or hearing impairments
  • Having severe contractures that limit participation in functional activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, ZEYTİNBURNU, 34015, Turkey (Türkiye)

Location

Related Publications (2)

  • Adiguzel H, Kirmaci ZIK, Gogremis M, Kirmaci YS, Dilber C, Berktas DT. The effect of proprioceptive neuromuscular facilitation on functional skills, muscle strength, and trunk control in children with cerebral palsy: A randomized controlled trial. Early Hum Dev. 2024 May;192:106010. doi: 10.1016/j.earlhumdev.2024.106010. Epub 2024 Apr 15.

  • Abd-Elmonem AM, Ali HA, Saad-Eldien SS, El-Nabie WAA. Efficacy of plyometric exercises on upper extremity function, selective motor control and hand grip strength in children with unilateral cerebral palsy: A randomized controlled study. Physiother Res Int. 2024 Jan;29(1):e2061. doi: 10.1002/pri.2061. Epub 2023 Nov 3.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 12, 2025

Study Start

February 1, 2025

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations