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Cerebral Palsy (CP)TACT-CPNCT07800221

Targeted Muscle Activation During Strength Training for Children With CP

An observational study of Cerebral Palsy (CP), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Cerebral Palsy (CP)
How many people
30 participants
Where
1 siteBelgium
Study dates
1 Sep 2026to 28 Feb 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 12 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • Confirmed diagnosis of spastic cerebral palsy
  • Aged 5 - 12 years at the time of inclusion
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site
  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

    Kaat Desloovere, prof. dr., +3216338009, kaat.desloovere@kuleuven.be

Other trials in Belgium

About this study

Official title: Targeted Muscle Activation During Strength Training for Children With Cerebral Palsy

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.

Read the detailed description

CP causes primary neurological impairments such as spasticity, muscle weakness, and reduced selective motor control. Over time, these impairments contribute to secondary musculoskeletal changes, including muscle contractures and skeletal deformities, which further limit mobility and affect gait. Muscle weakness in CP is multifactorial and results not only from reduced force-generating capacity but also from impaired muscle activation, altered muscle morphology, and biomechanical disadvantages. Consequently, children may compensate through alternative muscle recruitment and altered movement strategies that offload weaker muscles.

Lower limb strength training is a common intervention and has shown benefits for muscle strength, gait, and gross motor function. However, findings across studies are highly variable. One potentially important but rarely examined factor is whether strengthening exercises activate the intended target muscles. Due to impaired selective motor control, children with CP may unintentionally train compensatory muscles rather than the weaker muscles that require strengthening.

To address this limitation, the present study proposes an activation-driven approach to lower limb strengthening. The protocol combines individualized exercise selection, EMG-biofeedback, and explicit management of compensatory mechanisms to promote more selective muscle activation. The ultimate goal is to improve training specificity and support the development of more effective strengthening interventions for children with spastic CP. The study specifically focuses on the gluteus maximus, vastus lateralis, and soleus, as these muscles play a crucial role in gait, are commonly weakened in CP, and may be offloaded through compensatory muscle recruitment.

In this prospective, [JV3.1]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. Visit 1 will evaluate 3-5 bodyweight exercise conditions per muscle group and select up to three individualized conditions based on target-muscle activation and compensatory mechanisms. Visit 2 will compare standardized instruction, patient-tailored verbal feedback, and visual single-target EMG feedback. Visit 3 will compare single-target EMG feedback with dual-target EMG feedback and combined EMG and biomechanical feedback. Surface EMG, three-dimensional motion capture, and force platforms will be used to assess the immediate effects of these conditions on target-muscle activation, compensatory muscle activity, and compensatory movement patterns.

Keywords
Spastic Cerebral Palsy, Electromyography, Biofeedback, Motion analysis, Targeted muscle activation, Lower limb strengthening
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07800221
Study groupRoleWhat they receive
Children with cerebral palsyChildren with spastic cerebral palsy, aged 5-12 years, GMFCS levels I-III

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Assessed across three study visits over approximately 4 weeks.

  2. 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.

    Measured: Assessed across three study visits over approximately 4 weeks.

  3. 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).

    Measured: Assessed across three study visits over approximately 4 weeks.

  4. 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.

    Measured: Assessed across three study visits over approximately 4 weeks.

  5. Joint angle compensation parameter

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

    Measured: Assessed across three study visits over approximately 4 weeks.

  6. Joint moment compensation parameter

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

    Measured: Assessed across three study visits over approximately 4 weeks.

  7. Joint power compensation parameter

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

    Measured: Assessed across three study visits over approximately 4 weeks.

Secondary outcomes (25)
  1. Continuous EMG waveforms

    Time-normalized EMG waveforms of target, antagonist, and compensatory muscles across the full exercise cycle and relevant task phases.

    Measured: Assessed across three study visits over approximately 4 weeks.

  2. Continuous joint angle waveforms

    Time-normalized joint angle waveforms across the full exercise cycle and task-specific phases. Values are expressed in degrees (°) and reported over 0-100% of the exercise cycle.

    Measured: Assessed across three study visits over approximately 4 weeks.

  3. Continuous joint moment waveforms

    Time-normalized joint moment waveforms across the full exercise cycle and task-specific phases. Values are expressed in Nm/kg and reported over 0-100% of the exercise cycle.

    Measured: Assessed across three study visits over approximately 4 weeks.

  4. Continuous joint power waveforms

    Time-normalized joint power waveforms across the full exercise cycle and task-specific phases. Values are expressed in W/kg and reported over 0-100% of the exercise cycle.

    Measured: Assessed across three study visits over approximately 4 weeks.

  5. Mean EMG amplitude

    Mean normalized EMG amplitude of the target muscle during the exercise, expressed as a percentage (%) relative to the reference signal used for EMG normalization.

    Measured: Assessed across three study visits over approximately 4 weeks.

  6. Muscle activation timing

    Activation onset and offset timing of the target muscle, determined from the normalized EMG signal and expressed in milliseconds (ms).

    Measured: Assessed across three study visits over approximately 4 weeks.

  7. Additional co-activation measures

    Co-activation indices (expressed in %) for other relevant muscle pairs, including agonist-antagonist and proximal-distal muscle combinations. Co-activation 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.

    Measured: Assessed across three study visits over approximately 4 weeks.

  8. Additional selectivity measures

    Selectivity ratios involving other target, synergistic, antagonist, or compensatory muscles to further describe the specificity of muscle recruitment. The selectivity ratio is calculated as the integrated EMG of the point-by-point ratio between the time-normalized activation waveform of the target muscle and the corresponding activation waveform of the comparison muscle. Values are expressed as a %, with higher values indicating greater selective activation of the target muscle relative to the comparison muscle.

    Measured: Assessed across three study visits over approximately 4 weeks.

  9. Additional kinematic parameters

    Exercise-specific kinematic variables, including joint range of motion, peak joint angles, trunk inclination, pelvic movement, knee position, ankle strategy. Values are expressed in degrees (°).

    Measured: Assessed across three study visits over approximately 4 weeks.

  10. Peak joint moments

    Exercise-specific peak joint moments. Values are expressed in Nm/kg.

    Measured: Assessed across three study visits over approximately 4 weeks.

  11. Peak joint powers

    Exercise-specific peak joint powers. Values are expressed in W/kg.

    Measured: Assessed across three study visits over approximately 4 weeks.

  12. Movement variability

    Variability of biomechanical parameters across repeated exercise trials, calculated as the standard deviation of the parameter of interest.

    Measured: Assessed across three study visits over approximately 4 weeks.

  13. Number of repetitions completed

    Number of exercise repetitions successfully completed during the exercise task.

    Measured: Assessed across three study visits over approximately 4 weeks.

  14. Exercise duration parameters

    Task execution measures including movement duration and task phase duration during strengthening exercises. Values are expressed in seconds.

    Measured: Assessed across three study visits over approximately 4 weeks.

  15. Task execution success

    Success of task execution during strengthening exercises, expressed as the proportion of successfully completed repetitions to the total number of attempted repetitions.

    Measured: Assessed across three study visits over approximately 4 weeks.

  16. Ability to perform the exercise under feedback conditions

    Ability to perform the exercise across the different feedback conditions, expressed as the proportion of feedback conditions in which the participant is able to complete the exercise.

    Measured: Assessed across three study visits over approximately 4 weeks.

  17. Maximal isometric strength

    Maximal voluntary isometric strength of the hip extensors (HE), knee extensors (KE), and plantar flexors (PF), measured with a hand-held dynamometer during the maximal voluntary isometric contraction (MVIC) procedures to characterize participant-specific strength capacity.

    Measured: Assessed across three study visits over approximately 4 weeks.

  18. Age

    Age of the participant at study inclusion (expressed in years).

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  19. Sex

    Sex of the participant (male, female, other).

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  20. Gross Motor Function Classification System (GMFCS) level

    GMFCS Levels I-III (higher levels indicate greater functional limitation).

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  21. General treatment history

    General treatment history relevant to the management of cerebral palsy.

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  22. Previous strength training experience

    Previous participation in strength training activities.

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  23. Botulinum neurotoxin history

    Previous treatment with botulinum neurotoxin.

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  24. Orthopaedic surgery history

    Previous lower-limb orthopaedic surgery.

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

  25. Use of orthoses or assistive devices

    Current use of orthoses or assistive devices.

    Measured: Collected during screening and/or Visit 1, before the experimental exercise assessments.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

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
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800221
Sponsor's protocol ID
S72414
Acronym
TACT-CP
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy (CP), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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 Belgium. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jolien Vanloocke (+32 16 34 10 16, jolien.vanloocke@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak EMG amplitude of the target muscles (time frame: Assessed across three study visits over approximately 4 weeks.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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