Clinical trial NCT06667518: Lower Extremity Neuromuscular Assessment in Children with Cerebral Palsy
Official title: Reliability and Feasibility of Lower Extremity Dynamometry and Electromyography Assessment in Children with Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Force Measurement
Electromyography
Children
Cerebral Palsy
Lower Limb
Keywords: dynamometry
electromyography
cerebral palsy
child
lower limb
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Muscle Strength
timeFrame: Through study completion, an average of 5 months
measure: Average Muscle Activation
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
measure: Muscle Tone
timeFrame: Through study completion, an average of 5 months
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Department of Physiotherapy - University of Thessaly
state: Phthiotis
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.