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NCT Number: NCT03863197

Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy

A randomized controlled trail will be carried out to investigate the effect of a 12-week supervised home-based progressive strength intervention in children with spastic cerebral palsy aged 5-11 years. The results of this strength intervention aiming for increased strength and muscle hypertrophy will serve as input for a clinical decision making framework based on muscle and tendon architecture.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiteit Gent, Ghent, Belgium

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About this study

Background: The alterations of morphological muscle and tendon properties are a primary determinant of the pathological muscle behaviour in spastic cerebral palsy (SCP). As treatments aim to reduce the progressive secondary problems, they are mainly directed at the muscle level. Muscle morphology features like volume, fascicle architecture and tendon properties are all responsive to treatment, but these treatment responses seem to be both patient and muscle-specific. Therefore, objective tools and protocols are needed for the evaluation of morphological muscle and tendon (MMT) properties in routine clinical practice. These are required to guide the patient-specific selection of appropriate, rationalized treatment choices and to determine the impact of these treatments on the MMT properties, the muscular impairment and function in children with SCP.

This intervention study is one out of three intervention studies focused on defining the effects of conservative treatments (strengthening, stretching and botulinum toxin injections) on muscle and tendon architecture. In this phase of the Treatment Algorithms based on Muscle and Tendon Morphology (TAMTA) project, we aim to develop specific guidelines for these treatment options linked to the MMT evaluation protocol. To achieve this goal, prediction models based on baseline MMT parameters for the prognosis of specific treatment outcomes will be developed from the data of the three intervention studies.

Aim: (1) determine whether the 12-week program of targeted progressive strengthening of the plantar flexors, the knee flexors and extensors leads to changes in the MMT properties of medial gastrocnemius, semitendinosus and rectus femoris, in the muscle strength and in gross motor function; and (2) determine the correlation between baseline MMT properties and the changes in the outcome parameters.

Methods/Design: A randomized controlled trial will be conducted in 40 ambulatory children with a confirmed diagnosis of SCP between 5 and 11 years of age. Participants will be randomized to the intervention group (who will additionally receive the strengthening program while continuing their usual care) or to the waitlist-control group (who will continue their usual care without additional treatment) using the randomization by minimization method (with influencing characteristics age and GMFCS level). Participants in the control group will be able to participate in the intervention after the control period. The MMT parameters of the medial gastrocnemius, tibialis anterior, semitendinosus and rectus femoris and the isometric and functional strength for the 4 related lower limb muscle groups (plantar flexors, dorsiflexors, knee flexors and knee extensors) as well as the gross motor function will be assessed before and after the 12-week program. After 6 weeks a short evaluation of the MMT parameters, isometric and functional strength will take place.

The change in primary outcome parameters before and after training of the intervention group will be compared to the data behaviour of the control group. Secondly, to explore the predictive value of specific baseline MMT parameters on treatment effect, both univariate and multivariate linear regression analyses will be conducted to identify significant predictive variables for the primary outcome parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of SCP
  • Aged 5-12 years
  • GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
  • Sufficient cooperation to comprehend and complete the test procedure

Exclusion criteria

  • Non-ambulatory
  • Botulinum toxin A injections six months prior to enrollment
  • Lower limb surgery two years prior to enrollment
  • Presence of ataxia or dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)

Treatment and study plan

Progressive strength training

Behavioral

Progressive Supervised Home-based Strength Training

Primary outcomes

  1. Change in Muscle Size Parameter

    Time frame: baseline, post-intervention (12-weeks)

    Estimation of muscle volume by 3D freehand ultrasonography.

  2. Change in Muscle Length

    Time frame: baseline, post-intervention (12-weeks)

    Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.

  3. Change in Echogenicity Intensity

    Time frame: baseline, post-intervention (12-weeks)

    Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values ranging from 0 to 255). Echogenicity intensity was defined over the whole muscle volume.

    Echogenicity intensity refers to the brightness of a muscle seen on the ultrasound image, which reflects how much sound is being bounced back (or "echoed") by the tissue. Higher echo-intensity (i.e., higher values) often indicates increased fat or fibrous tissue within the muscle and is therefore seen as a worse outcome. Whereas low echo-intensity (i.e., lower values) indicate less non-muscular tissue in the muscle, therefor higher quality and a better outcome.

  4. Change in Isometric Muscle Strength

    Time frame: baseline, post-intervention (12-weeks)

    Evaluation of isometric muscle strength by Instrumented Weakness Assessment.

  5. Change in Functional Muscle Strength - Muscle Endurance

    Time frame: baseline, post-intervention (12-weeks)

    Evaluation of functional muscle strength by 30-sec maximum repetition tests of the Adapted Functional Strength measure.

    For unilateral exercises (lateral step-up and unilateral heel raise) all affected legs were assessed.

  6. Change in Functional Muscle Strength - Maximum Jumping Distance

    Time frame: baseline, post-intervention (12-weeks)

    Evaluation of standing long jump by the Adapted Functional Strength measure.

Secondary outcomes

  1. Change in Gross Motor Function

    Time frame: baseline, post-intervention (12 weeks)

    Evaluation of gross motor function by the Gross Motor Function Measure (GMFM) item set. The GMFM is a standardized observational tool used to assess motor function in children with cerebral palsy by evaluating specific physical tasks across five areas: lying & rolling, sitting, crawling & kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point scale: 0 (does not initiate), 1 (initiates but completes less than 10%), 2 (partially completes, 10% to less than 100%), and 3 (fully completes). Higher scores indicate better gross motor function, with a maximum of 66.

  2. Change in Walking Capacity

    Time frame: baseline, post-intervention (12 weeks)

    Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test

Other outcomes

  1. Change in Quality of Life

    Time frame: baseline, post-intervention (12 weeks)

    Evaluation of quality of life by the CP Quality of Life (CP QOL-Child) questionnaire for children. This questionnaire evaluates quality of life over various domains on a 1-9 scale. A higher score indicates more happiness.

  2. Change in Functionality

    Time frame: baseline, post-intervention (12 weeks)

    The level of functionality and activity is assessed by the Gillette Functional Assessment questionnaire. This parent-reported questionnaire consists of 22 items (0 low function - 10 high function).

  3. Change in Patient Reported Physical Function

    Time frame: Baseline, post-intervention (12 weeks)

    The perceived level of physical functioning is assessed by the Activities Scale for Kids

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven
  • Queen Fabiola Children's University Hospital
  • University Ghent

Registry information

Official study title

Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2019
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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