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Cerebral Palsy (CP)PNF vs PLY-UCPNCT07116798

Upper Extremity Strengthening Interventions in Children With UCP

A study testing Exercise in people with Cerebral Palsy (CP), run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to 7 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Biruni University

    Istanbul, ZEYTİNBURNU, 34015

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Different Upper Extremity Strengthening Exercises in Children With Unilateral Spastic Type Cerebral Palsy

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.

Being tested
Exercise
Keywords
cerebral palsy, upper extremity, strengthening
Medical subject headings
Cerebral Palsy

What participants receive

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

  • ExerciseOther

    Strengthening Exercises Based on Proprioceptive Neuromuscular Facilitation Patterns

  • ExerciseOther

    Plyometric Exercises

Study groups in NCT07116798
Study groupRoleWhat they receive
PNF Group (Strengthening Based on Proprioceptive Neuromuscular Facilitation Patterns)ExperimentalThe 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.
Receives: Other: Exercise
Plyometric Group (Plyometric Exercises)ExperimentalParticipants 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.
Receives: Other: Exercise

What is being measured

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

  1. 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.

    Measured: Baseline and after 8-weeks

  2. 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.

    Measured: Baseline and after 8-weeks

  3. 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).

    Measured: Baseline and after 8-weeks

Secondary outcomes (2)

  1. Quality of Upper Extremity Skills Test-QUEST

    The Quality of Upper Extremity Skills Test (QUEST) is designed to assess upper extremity movement quality and hand function in children with cerebral palsy. It includes subtests for dissociated movements, grasp, weight-bearing, protective extension, hand function rating, spasticity grading, and cooperation. Each item is scored on a 3-point scale (0-2), based on whether the movement is successfully performed. The total score reflects the functional quality of the affected upper limb. The administration time is approximately 20-30 minutes.

    Measured: Baseline and after 8-weeks

  2. ABILHAND- Kids

    ABILHAND-Kids is a functional scale used to assess manual ability in children with cerebral palsy and other pediatric neurological disorders. It supports treatment planning and goal setting by evaluating the child's ability to perform daily activities requiring hand use. The scale consists of 21 items, most involving bimanual tasks, and measures the perceived difficulty of these activities as reported by parents. Each item is rated on a 3-point ordinal scale: 0 = impossible, 1 = difficult, and 2 = easy. The scale provides insight into hand performance in self-care tasks from the caregiver's perspective.

    Measured: Baseline and after 8-weeks

Timeline

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

  1. First posted12 Aug 2025
  2. Study start1 Feb 2025
  3. Primary completion7 Jan 2026
  4. Study completion7 Jan 2026

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07116798
Sponsor's protocol ID
FTR-UCP-001
Acronym
PNF vs PLY-UCP
Status last verified
Apr 2026
First submitted
7 Aug 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38653163

  • 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.

    PubMed 37922449

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Cerebral Palsy (CP), run by Biruni University at 1 site in Turkey (Türkiye).

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 8 inclusion and 4 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: finished, as of the sponsor's last update on 8 Apr 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Thickness Measurement by Ultrasonography (time frame: Baseline and after 8-weeks). 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?

On the ClinicalTrials.gov record for NCT07116798, which also lists 2 linked publications.

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 8 Apr 2026.

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