- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667518
Knee Neuromuscular Assessment in Children With Cerebral Palsy
Reliability and Feasibility of Knee Traction Dynamometry and Electromyography 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Phthiotis
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Lamia, Phthiotis, Greece, 35132
- Department of Physiotherapy - University of Thessaly
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with Cerebral Palsy
Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Through study completion, an average of 5 months
|
|
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)
|
Through study completion, an average of 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Through study completion, an average of 5 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- neuromusc_knee_cp_child
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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