NCT07777809

Brief Summary

This observational cross-sectional study investigates the bilateral asymmetry of respiratory muscle activity during breathing in children with spastic cerebral palsy (CP). Children with CP often exhibit structural deformities, which may lead to impaired chest mobility and asymmetric respiratory function. The primary objective is to objectively evaluate the imbalance in the activation of bilateral respiratory muscles (intercostal, external oblique, and sternocleidomastoid) using non-invasive surface electromyography (sEMG). Muscle activity will be measured during resting breathing and active breathing tasks. The findings aim to provide clinical evidence for developing selective respiratory muscle training programs for this population.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Aug 2026Aug 2027

Study Start

First participant enrolled

August 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Surface ElectromyographyRespiratory MuscleAsymmetry

Outcome Measures

Primary Outcomes (2)

  • Root Mean Square (RMS) of Respiratory Muscle Activity

    Muscle activation amplitude of the intercostal, external oblique, and sternocleidomastoid muscles measured using surface electromyography (sEMG). The raw sEMG signals are full-wave rectified and smoothed using a 50ms moving window to calculate the RMS values during resting and active breathing tasks.

    Up to 30 minutes (measured once during the single-day assessment session)

  • Asymmetry Index (AI) of Respiratory Muscle Activation

    The asymmetry index will be calculated using the Root Mean Square (RMS) values obtained from surface electromyography (sEMG) . The formula used is (Right RMS - Left RMS) / (Right RMS + Left RMS) X 100 . The index evaluates the percentage of imbalance between the right and left respiratory muscles (intercostal, external oblique, and sternocleidomastoid) during resting breathing and active breathing tasks.

    Up to 30 minutes (measured once during the single-day assessment session)

Study Arms (1)

Spastic Cerebral Palsy Group

Children aged 4 to 12 years with spastic cerebral palsy, GMFCS level I-II, and TRACE score of 4 or higher.

Diagnostic Test: Surface Electromyography (sEMG) assessment

Interventions

Measuring the bilateral activation of respiratory muscles (intercostal, external oblique, and sternocleidomastoid) using sEMG under two conditions: 30 seconds of resting breathing and active breathing tasks (blowing a pinwheel or bubbles).

Spastic Cerebral Palsy Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 4 to 12 years diagnosed with spastic cerebral palsy who are receiving treatment at a local outpatient rehabilitation center (Easy Rehabilitation Medicine Clinic, Yongin-si, Gyeonggi-do, Republic of Korea).

You may qualify if:

  • Children with Gross Motor Function Classification System (GMFCS) Level I or II
  • Children with sufficient cognitive ability to understand instructions and voluntarily perform tasks
  • Children with a Trunk Appearance Clinical Evaluation (TRACE) score of 4 or higher out of a total of 12 points

You may not qualify if:

  • Children who have undergone orthopedic surgery of the spine or lower extremities, or received botulinum toxin injection treatment within the past 6 months
  • Children with acute or chronic respiratory diseases, such as asthma or acute pneumonia
  • Children with severe cardiac disorders, intellectual disabilities, or visual and auditory impairments that may interfere with the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Easy Rehabilitation Medicine Clinic

Yongin-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

ElectromyographyPhysical Examination

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • jemin Yoo

    Sahmyook University

    PRINCIPAL INVESTIGATOR
  • Seungwon Lee

    Sahmyook University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 20, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

August 20, 2026

Record last verified: 2026-08

Locations