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Completed

NCT Number: NCT06667518

Knee Neuromuscular Assessment in Children With Cerebral Palsy

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.

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Key information

Conditions

Force Measurement Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Children Electromyography Lower Limb Nervous System Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physiotherapy - University of Thessaly

Lamia, Phthiotis, 35132, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Muscle Strength

    Time frame: Through study completion, an average of 5 months

    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)

  2. Average Muscle Activation

    Time frame: Through study completion, an average of 5 months

    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)

Secondary outcomes

  1. Muscle Tone

    Time frame: Through study completion, an average of 5 months

    Evaluated using the Modified Ashworth Scale. Unit of Measure: Scoring Options (0-4) // (higher scores - worse outcome)

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

Reliability and Feasibility of Knee Traction Dynamometry and Electromyography Assessment in Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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