Lower Extremity Neuromuscular Assessment in Children with Cerebral Palsy

Recruiting

• Conditions: Force Measurement; Electromyography; Children; Cerebral Palsy; Lower Limb

• Registration Number: NCT06667518
• Lead Sponsor: University of Thessaly

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-20
• Status Verified: 2024-10
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-01
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle Strength	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	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 Outcome Measures

Name	Time	Method
Muscle Tone	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)

Trial Locations

Locations (1)

Department of Physiotherapy - University of Thessaly; 🇬🇷 Lamia, Phthiotis, Greece