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Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy

Sponsor
Ilke KARA (Other)
Overall Status
Completed
CT.gov ID
NCT05818839
Collaborator
(none)
80
Enrollment
1
Location
7.7
Actual Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility performance.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy
    Actual Study Start Date :
    Jul 1, 2022
    Actual Primary Completion Date :
    Nov 20, 2022
    Actual Study Completion Date :
    Feb 20, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    UCP

    Children diagnosed with unilateral spastic cerebral palsy
    TyD

    Typically developing children

    Outcome Measures

    Primary Outcome Measures

    1. The Pediatric Balance Scale [Baseline]

      The Pediatric Balance Scale assesses functional balance in three categories: self-care, mobility and social function, using 14 items. Each item is scored from 0 (indicating low function) to 4 (indicating highest function), with a maximum score of 56 points. A higher score indicates better balance.

    2. Trunk Control Measurement Scale [Baseline]

      The TCSM was used to assess seated trunk balance and consisted of 15 items. Each item was scored from 0 to 3, with 0 indicating inability to perform the task and 3 indicating the full performance of the item. A high score indicated good trunk control

    3. 2-Minute Walk Test [Baseline]

      The children were asked to walk at a normal pace, without running, and the distance they walked for 2 minutes was recorded.

    4. Timed Up and Go Test [Baseline]

      The children were seated with their feet in full contact with the floor, in a chair with back support only, and with their hip and knee joints at 90 degrees. On the start command, they were asked to walk 3 metres to the wall at a pace they felt comfortable with and then sit back down in the chair.

    5. Muscle tone (Hz) [Baseline]

      The muscle tone which is a biomechanical property of the muscles evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.

    6. Stiffness (N/m) [Baseline]

      The stiffness which is a biomechanical property of muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria for unilateral spastic cerebral palsy were:

    • aged between 4 and 12 years,

    • spasticity level MAS≤2,

    • mental level sufficient to understand commands given,

    • and ambulation without the use of an orthosis or other device. In addition, children had to be GMFCS level I or II.

    Exclusion criteria were:

    • a history of spinal surgery or spinal orthosis use,

    • uncorrected vision or hearing problems,

    • severe epileptic seizures,

    • lower extremity contractures,

    • botulinum toxin A injection in the previous six months,

    • lower extremity surgery in less than one year,

    • use of pharmacological agents that affect muscle tone,

    • and poor cooperation.

    Inclusion criteria for controls were:

    • aged between 4 and 12 years,

    • no neurological or orthopaedic diagnosis,

    • no known systemic problems,

    • normal vision and hearing,

    • and a mental level sufficient to understand the commands given.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Okan University Istanbul Turkey 34959

    Sponsors and Collaborators

    • Ilke KARA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ilke KARA, Co-Investigator, Dokuz Eylul University
    ClinicalTrials.gov Identifier:
    NCT05818839
    Other Study ID Numbers:
    • BEU-CP-01
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 19, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ilke KARA, Co-Investigator, Dokuz Eylul University
    postural balance
    muscle properties
    mobility
    paralysis
    children
    Additional relevant MeSH terms:
    Cerebral Palsy

    Study Results

    No Results Posted as of Apr 19, 2023