Knee Neuromuscular Assessment in Children With Cerebral Palsy

NCT06667518 | Completed

• 1 other identifier: neuromusc_knee_cp_child
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the reliability (intra-rater and inter-rater) of the K-Pull dynamometer and the K-Myo non-invasive electromyography sensor (assessing neuromuscular activity) in the evaluation of the lower limbs in children with cerebral palsy. Specific objectives include:

• Examining differences in neuromuscular activity among children with CP classified at functional levels I to III on the GMFCS scale.
• Deriving conclusions from the correlation between electromyographic activity, muscle tone, and generated muscle strength.
• Assessing the applicability of neuromuscular activity assessment devices in clinical settings.

Conditions

Force Measurement; Electromyography; Children; Cerebral Palsy; Lower Limb

Keywords

dynamometry; electromyography; cerebral palsy; child; lower limb

Outcome Measures

Primary Outcomes (2)

• Muscle Strength

  Average Peak Force refers to the average highest force output recorded during isometric contractions and represents the maximal strength generated by the muscle group being assessed (e.g., hip or knee flexors and extensors). Unit of Measure: Newton (N)

  Through study completion, an average of 5 months

• Average Muscle Activation

  Average activation in the context of surface electromyography refers to the mean level of electrical activity detected from muscle fibers over a specific period. Unit of Measure: millivolt (mV)

  Through study completion, an average of 5 months

Secondary Outcomes (1)

• Muscle Tone

  Through study completion, an average of 5 months

Study Arms (1)

Children with Cerebral Palsy

Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III.

Device: Neuromuscular Activity Assessment

Interventions

Neuromuscular Activity Assessment DEVICE

K-Pull dynamometer is an assessment tool used to quantify muscle strength. It uses traction through a non-elastic strap to facilitate isometric contractions. K-Myo (non-invasive EMG sensor) is an assessment tool used to detect muscle activation and tracking patient's improvement.

Children with Cerebral Palsy

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III based on specific inclusion and exclusion criteria to ensure the reliability and feasibility of traction dynamometry and surface electromyography assessment.

You may qualify if:

• children with spastic type cerebral palsy (CP),
• aged between 5 and 16 years,
• classified at GMFCS levels I to III,
• voluntary motor control,
• ambulatory, with or without the use of mobility aids,
• can understand and execute verbal commands.

You may not qualify if:

• have previously undergone interventions that affect neuromuscular performance (such as surgery or botulinum toxin injections)
• have sustained an injury,
• demonstrate a low level of compliance.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Department of Physiotherapy - University of Thessaly

Lamia, Phthiotis, 35132, Greece

Location

Related Publications (3)

• Mulder-Brouwer AN, Rameckers EA, Bastiaenen CH. Lower Extremity Handheld Dynamometry Strength Measurement in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 Summer;28(2):136-53. doi: 10.1097/PEP.0000000000000228.

  PMID: 26744991 BACKGROUND

• Aertssen W, Smulders E, Smits-Engelsman B, Rameckers E. Functional strength measurement in cerebral palsy: feasibility, test-retest reliability, and construct validity. Dev Neurorehabil. 2019 Oct;22(7):453-461. doi: 10.1080/17518423.2018.1518963. Epub 2018 Sep 12.

  PMID: 30207812 BACKGROUND

• Cappellini G, Sylos-Labini F, Assenza C, Libernini L, Morelli D, Lacquaniti F, Ivanenko Y. Clinical Relevance of State-of-the-Art Analysis of Surface Electromyography in Cerebral Palsy. Front Neurol. 2020 Dec 11;11:583296. doi: 10.3389/fneur.2020.583296. eCollection 2020.

  PMID: 33362693 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 31, 2024
• Study Start: September 20, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)