Lower Extremity Neuromuscular Assessment in Children with Cerebral Palsy

NCT ID: NCT06667518

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-20

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Force Measurement Electromyography Children Cerebral Palsy Lower Limb

Keywords

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dynamometry electromyography cerebral palsy child lower limb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with Cerebral Palsy

Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III.

Neuromuscular Activity Assessment

Intervention Type DEVICE

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.

Interventions

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Neuromuscular Activity Assessment

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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George Paras

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physiotherapy - University of Thessaly

Lamia, Phthiotis, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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George Paras, Ph.D.

Role: CONTACT

Phone: 22310 60234

Email: [email protected]

Facility Contacts

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George Paras, Ph.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26744991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30207812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33362693 (View on PubMed)

Other Identifiers

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neuromusc-cp-child

Identifier Type: -

Identifier Source: org_study_id