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

28 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

30

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Bélgica
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Bélgica, 3000

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Peak EMG amplitude of the target muscles
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Continuous EMG waveforms
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universitaire Ziekenhuizen KU Leuven

Investigadores

  • Investigador principal: Kaat Desloovere, Prof. dr., Department of Rehabilitation Sciences, KU Leuven, Belgium

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

28 de fevereiro de 2029

Conclusão do estudo (Estimado)

28 de fevereiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de agosto de 2026

Primeira postagem (Real)

2 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • S72414

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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