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Clinical Trials/NCT06667518
NCT06667518
Completed
Not Applicable

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

University of Thessaly1 site in 1 country20 target enrollmentSeptember 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Force Measurement
Sponsor
University of Thessaly
Enrollment
20
Locations
1
Primary Endpoint
Muscle Strength
Status
Completed
Last Updated
4 months ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
September 20, 2024
End Date
March 1, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

George Paras

Assistant Professor

University of Thessaly

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

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

  • Muscle Tone(Through study completion, an average of 5 months)

Study Sites (1)

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