Force MeasurementNCT06667518
Knee Neuromuscular Assessment in Children With Cerebral Palsy
An observational study of Force Measurement and Electromyography, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Force Measurement, Electromyography, Children
- What is being tested?
- Neuromuscular Activity Assessment
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 20 Sep 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy - University of Thessaly
Lamia, Phthiotis, 35132
About this study
Official title: 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.
- Conditions
- Force Measurement, Electromyography, Children, Cerebral Palsy, Lower Limb
- Being tested
- Neuromuscular Activity Assessment
- Keywords
- dynamometry, electromyography, cerebral palsy, child, lower limb
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Activity AssessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy | Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III. Receives: Device: Neuromuscular Activity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
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)
Measured: Through study completion, an average of 5 months
Average Muscle Activation
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)
Measured: Through study completion, an average of 5 months
Secondary outcomes (1)
Muscle Tone
Evaluated using the Modified Ashworth Scale. Unit of Measure: Scoring Options (0-4) // (higher scores - worse outcome)
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start20 Sep 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Force MeasurementStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Paras, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667518
- Sponsor's protocol ID
- neuromusc_knee_cp_child
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26744991Aertssen 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.
PubMed 30207812Cappellini 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.
PubMed 33362693
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Feasibility of Knee Traction Dynamometry and Electromyography Assessment in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06667518
- Acronym / sponsor ID
- neuromusc_knee_cp_child
- Conditions
- Force Measurement, Electromyography, Children, Cerebral Palsy, Lower Limb
- Keywords
- dynamometry, electromyography, cerebral palsy, child, lower limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy | – | Device: Neuromuscular Activity AssessmentChildren with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Activity AssessmentK-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. | Device | Children with Cerebral Palsy |
Primary outcome
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)
1 secondary outcome
Muscle Tone
Time frame: Through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 26744991Mulder-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.
- Background: PubMed 30207812Aertssen 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.
- Background: PubMed 33362693Cappellini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Force Measurement and Electromyography, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: Through study completion, an average of 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06667518, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.