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Targeted Muscle Activation During Strength Training for Children With CP (TACT-CP)

28. srpna 2026 aktualizováno: Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven

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.

Přehled studie

Postavení

Zatím nenabíráme

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

30

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgie, 3000

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Peak EMG amplitude of the target muscles
Časové okno: Assessed across three study visits over approximately 4 weeks.
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
Časové okno: Assessed across three study visits over approximately 4 weeks.
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
Časové okno: Assessed across three study visits over approximately 4 weeks.

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
Časové okno: Assessed across three study visits over approximately 4 weeks.
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
Časové okno: Assessed across three study visits over approximately 4 weeks.
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
Časové okno: Assessed across three study visits over approximately 4 weeks.
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
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Continuous EMG waveforms
Časové okno: Assessed across three study visits over approximately 4 weeks.
Time-normalized EMG waveforms of target, antagonist, and compensatory muscles across the full exercise cycle and relevant task phases.
Assessed across three study visits over approximately 4 weeks.
Continuous joint angle waveforms
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.
Assessed across three study visits over approximately 4 weeks.
Continuous joint moment waveforms
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.
Assessed across three study visits over approximately 4 weeks.
Continuous joint power waveforms
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.
Assessed across three study visits over approximately 4 weeks.
Mean EMG amplitude
Časové okno: Assessed across three study visits over approximately 4 weeks.
Mean normalized EMG amplitude of the target muscle during the exercise, expressed as a percentage (%) relative to the reference signal used for EMG normalization.
Assessed across three study visits over approximately 4 weeks.
Muscle activation timing
Časové okno: Assessed across three study visits over approximately 4 weeks.
Activation onset and offset timing of the target muscle, determined from the normalized EMG signal and expressed in milliseconds (ms).
Assessed across three study visits over approximately 4 weeks.
Additional co-activation measures
Časové okno: Assessed across three study visits over approximately 4 weeks.

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.

Assessed across three study visits over approximately 4 weeks.
Additional selectivity measures
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.
Assessed across three study visits over approximately 4 weeks.
Additional kinematic parameters
Časové okno: Assessed across three study visits over approximately 4 weeks.
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 (°).
Assessed across three study visits over approximately 4 weeks.
Peak joint moments
Časové okno: Assessed across three study visits over approximately 4 weeks.
Exercise-specific peak joint moments. Values are expressed in Nm/kg.
Assessed across three study visits over approximately 4 weeks.
Peak joint powers
Časové okno: Assessed across three study visits over approximately 4 weeks.
Exercise-specific peak joint powers. Values are expressed in W/kg.
Assessed across three study visits over approximately 4 weeks.
Movement variability
Časové okno: Assessed across three study visits over approximately 4 weeks.
Variability of biomechanical parameters across repeated exercise trials, calculated as the standard deviation of the parameter of interest.
Assessed across three study visits over approximately 4 weeks.
Number of repetitions completed
Časové okno: Assessed across three study visits over approximately 4 weeks.
Number of exercise repetitions successfully completed during the exercise task.
Assessed across three study visits over approximately 4 weeks.
Exercise duration parameters
Časové okno: Assessed across three study visits over approximately 4 weeks.
Task execution measures including movement duration and task phase duration during strengthening exercises. Values are expressed in seconds.
Assessed across three study visits over approximately 4 weeks.
Task execution success
Časové okno: Assessed across three study visits over approximately 4 weeks.
Success of task execution during strengthening exercises, expressed as the proportion of successfully completed repetitions to the total number of attempted repetitions.
Assessed across three study visits over approximately 4 weeks.
Ability to perform the exercise under feedback conditions
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.
Assessed across three study visits over approximately 4 weeks.
Maximal isometric strength
Časové okno: Assessed across three study visits over approximately 4 weeks.
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.
Assessed across three study visits over approximately 4 weeks.
Age
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
Age of the participant at study inclusion (expressed in years).
Collected during screening and/or Visit 1, before the experimental exercise assessments.
Sex
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
Sex of the participant (male, female, other).
Collected during screening and/or Visit 1, before the experimental exercise assessments.
Gross Motor Function Classification System (GMFCS) level
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
GMFCS Levels I-III (higher levels indicate greater functional limitation).
Collected during screening and/or Visit 1, before the experimental exercise assessments.
General treatment history
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
General treatment history relevant to the management of cerebral palsy.
Collected during screening and/or Visit 1, before the experimental exercise assessments.
Previous strength training experience
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
Previous participation in strength training activities.
Collected during screening and/or Visit 1, before the experimental exercise assessments.
Botulinum neurotoxin history
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
Previous treatment with botulinum neurotoxin.
Collected during screening and/or Visit 1, before the experimental exercise assessments.
Orthopaedic surgery history
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
Previous lower-limb orthopaedic surgery.
Collected during screening and/or Visit 1, before the experimental exercise assessments.
Use of orthoses or assistive devices
Časové okno: Collected during screening and/or Visit 1, before the experimental exercise assessments.
Current use of orthoses or assistive devices.
Collected during screening and/or Visit 1, before the experimental exercise assessments.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kaat Desloovere, Prof. dr., Department of Rehabilitation Sciences, KU Leuven, Belgium

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

28. února 2029

Dokončení studie (Odhadovaný)

28. února 2029

Termíny zápisu do studia

První předloženo

24. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

28. srpna 2026

První zveřejněno (Aktuální)

2. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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