NCT07800221

Brief Summary

Cerebral palsy (CP) is the most common cause of physical disability in children and is associated with muscle weakness, spasticity, and impaired motor control. These impairments often lead to compensatory movement strategies, in which other muscles are recruited or movements are adapted to offload weaker target muscles. Although lower limb strengthening is widely used to improve motor function in children with CP, outcomes remain inconsistent. One potentially important but rarely examined factor is whether the intended muscles are actually activated during training. This study aims to develop and apply an activation-driven assessment protocol that combines individualized exercise selection, real-time electromyography (EMG) biofeedback, and compensation monitoring to identify conditions that promote target-muscle activation while limiting compensatory mechanisms. The focus is on three key muscle groups: hip extensors (HE), knee extensors (KE), and plantar flexors (PF). In this prospective\[JV2.1\], within-subject repeated-measures study, 30 ambulant children aged 5-12 years with spastic CP and Gross Motor Function Classification System levels I-III will complete three assessment visits in which exercise conditions and feedback strategies are compared using surface EMG and three-dimensional movement analysis.

Trial Health

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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
29mo left

Started Sep 2026

Typical duration 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 Progress4%
Sep 2026Feb 2029

First Submitted

Initial submission to the registry

August 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

August 24, 2026

Last Update Submit

August 28, 2026

Conditions

Keywords

Spastic Cerebral PalsyElectromyographyBiofeedbackMotion analysisTargeted muscle activationLower limb strengthening

Outcome Measures

Primary Outcomes (7)

  • Peak EMG amplitude of the target muscles

    Peak normalized EMG amplitude during the exercise, used as a measure of maximal targeted activation of the hip extensors (HE), knee extensors (KE), and plantar flexors (PF).

    Assessed across three study visits over approximately 4 weeks.

  • Integrated EMG of the target muscles

    Integrated normalized EMG over the duration of the complete task or phase of interest, used as a measure of total targeted muscle activation.

    Assessed across three study visits over approximately 4 weeks.

  • Co-activation index

    Quantification of simultaneous activation of the target muscle and relevant antagonist or compensatory muscle, used to assess co-activation during strengthening exercises. It is calculated as: Co-activation index (%) = 2 × (Common Area of A and B / (Area of A + Area of B)) × 100 where A and B represent the two muscles being compared. Values range from 0% to 100%, with higher values indicating greater simultaneous muscle activation (co-activation).

    Assessed across three study visits over approximately 4 weeks.

  • Selectivity ratio

    Integrated EMG of the point-by-point ratio between the time-normalized activation waveform of the target muscle and the corresponding activation waveform of a relevant synergistic or compensatory muscle, used as a measure of target muscle selectivity during the exercise.

    Assessed across three study visits over approximately 4 weeks.

  • Joint angle compensation parameter

    A predefined joint angle (expressed in °) selected according to the exercise task, used to quantify compensatory movement strategies.

    Assessed across three study visits over approximately 4 weeks.

  • Joint moment compensation parameter

    A predefined joint moment (expressed in Nm/kg) selected according to the exercise task, used to quantify compensatory movement strategies.

    Assessed across three study visits over approximately 4 weeks.

  • Joint power compensation parameter

    A predefined joint power (expressed in W/kg) selected according to the exercise task, used to quantify compensatory movement strategies.

    Assessed across three study visits over approximately 4 weeks.

Secondary Outcomes (25)

  • Continuous EMG waveforms

    Assessed across three study visits over approximately 4 weeks.

  • Continuous joint angle waveforms

    Assessed across three study visits over approximately 4 weeks.

  • Continuous joint moment waveforms

    Assessed across three study visits over approximately 4 weeks.

  • Continuous joint power waveforms

    Assessed across three study visits over approximately 4 weeks.

  • Mean EMG amplitude

    Assessed across three study visits over approximately 4 weeks.

  • +20 more secondary outcomes

Study Arms (1)

Children with cerebral palsy

Children with spastic cerebral palsy, aged 5-12 years, GMFCS levels I-III

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with spastic cerebral palsy, who have routine follow-up care at the CP reference center of the university hospitals Leuven

You may qualify if:

  • Confirmed diagnosis of spastic cerebral palsy
  • GMFCS level I - III
  • At least 3 months post-injection with Botulinum neurotoxin in muscles relevant to the target or compensatory activation patterns (rationale: there is no expected residual neuromuscular effect of Botulinum neurotoxin injections on muscle activation patterns ≥3 months post Botulinum neurotoxin injection)
  • ≥12 months post lower-limb orthopaedic surgery

You may not qualify if:

  • Dyskinetic or ataxic cerebral palsy
  • Severe spasticity (Modified Ashworth ≥3)
  • Severe bony deformities or comorbidities precluding valid assessments
  • Insufficient ability to understand instructions or cooperate with the assessment procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kaat Desloovere, Prof. dr.

    Department of Rehabilitation Sciences, KU Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 2, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

September 2, 2026

Record last verified: 2026-08

Locations