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Cerebral Palsy (CP)NCT07616193

Interaction Between Spasticity and the Initial Response After Balance Perturbations in Children With Spastic Cerebral Palsy

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to investigate the link between spasticity and the initial response after standing balance perturbations in children with spastic cerebral palsy. Reactive balance performance was tested using a moving platform. Read more about this study

Who is it for?
Ages 5 to 17 yearsHealthy volunteers can take part
How many people
40 participants
Where
1 siteBelgium
Study dates
13 Mar 2020to 30 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

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 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children with spastic cerebral palsy, who have routine follow-up care at the CP reference center of the university hospitals Leuven. Typically developing children are recruited through the social and professional network of involved researchers and thesis studies, who approach participants through flyers and social media.

Who may be able to join

  • Diagnosis of cerebral palsy
  • Spasticity as defined by clinical assessment
  • Aged between 5-17 years old
  • Gross motor classification scale I-III
  • Able to stand independently for at least 10 minutes
  • Aged between 5 and 17 years old
  • Good health

Who cannot join

  • Orthopedic/neurological surgery in the previous year
  • Botulinum neurotoxin injections in the past 6 months
  • Presence of ataxia or dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities
  • Typically developing children:
Show all 9Show fewer
  • Presence of neuro-musculoskeletal or vestibular diseases
  • Lower limb injuries during the past 6 months
  • Irritated skin or open wounds where sensors will be placed (CP en TD)

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Official title: Association Between the Initial Response After Perturbation to Standing Balance and Spasticity Measurements (1) and Kinematic Response Strategy to Restore Balance (2) in Children With Spastic Cerebral Palsy

The aim of this study was to investigate the link between spasticity and the initial response after standing balance perturbations in children with spastic cerebral palsy. Reactive balance performance was tested using a moving platform. The investigators provided two types of perturbations, (1) backward translations and (2) rotations towards dorsiflexion, of different magnitudes. Spasticity was assessed using instrumented clinical tests of spasticity as the pendulum test and isolated passive joint rotations. Kinematics and EMG were measured simultaneously.

Read the detailed description

Background:

Spasticity is a common impairment following an upper motor neuron lesion, such as cerebral palsy (CP). Children with CP suffer a lot from balance impairments, which will impair their participation in daily life activities. When clinically assessing spasticity, a passive muscle is stretched and spasticity is scored based on the observed resistance against this stretch. Similar muscle stretches also occur when standing balance is perturbed, as for example when standing on a departing bus or walking on uneven terrain.

Maintaining balance involves complex sensorimotor transformations to activate the muscle to produce the required balance correcting response. Sensorimotor processing refers to how the nervous system translates incoming sensory information about body motion into motor commands to activate muscles. In both healthy animals and humans, sensorimotor processes underlying reactive standing balance can be explained by delayed feedback from CoM kinematics. The sensitivity to the CoM disturbance have been shown to be relatively constant within one subject, but change with age, age-related cognitive decline, sensory deficits, and neurological impairments.

Both kinematic and muscle responses to perturbations of standing balance are impaired in children with CP. Children with CP have a higher chance of losing their balance, change to a stepping strategy at lower perturbation levels, and have increased muscle (co-)activation. However, it is unknown whether the underlying sensorimotor transformations are altered in CP and how these changes contribute to the altered balance responses observed in CP. Therefore, the first aim was to understand alterations in sensorimotor processing underlying reactive standing balance control in children with spastic CP.

The increased muscle co-activation that is observed in CP might be a functional compensation strategy to improve balance control. For example, muscle co-activation will increase joint stiffness and therefore resisting movement of the body with respect to the feet during backward translational perturbations. In this case, co-activation will help to maintain balance. However, it is not clear whether children with CP use the increased co-activation as compensation strategy to improve balance control or whether the muscle co-activation is a consequence of impaired balance control. When standing balance is perturbed using rotational perturbations, muscle co-activation will hinder balance control. Increased muscle co-activation and the following increased joint stiffness will couple body movement to platform movement resulting in body tilt. Hence, increasing joint stiffness might not be beneficial during rotational perturbations. Our second aim was to investigate whether children with CP use increased muscle co-activation as a compensation strategy to improve balance control or whether muscle co-activation causes balance control impairments by combining translational and rotational perturbations of standing balance.

Muscle stretches occur during isolated joint rotations, as clinically applied when assessing joint hyper-resistance, and during perturbations of standing balance. Children with CP respond to both isolated joint rotations and perturbations of standing with increased excitation of the stretched muscle, combined with increased agonist-antagonist co-activation. Although the striking similarities between both reactive muscle responses to muscle stretches, little is known about the relation between joint hyper-resistance and reactive balance. Therefore our third aim was to explore the relation between muscle responses to instrumented tests of joint hyper-resistance and translational and rotational perturbations of standing balance.

Methods:

Twenty children with CP and twenty age-matched typically developing (TD) children participated in this study. Children with CP were diagnosed by a neuro-pediatrician and met the following inclusion criteria: (1)aged between 5 and 17 years old; (32) Gross Motor Classification Scale I-III; (3) able to stand independently for at least 10 minutes; (4) no orthopedic/neurological surgery in the previous year; and (5) no botulinum neurotoxin injections in the previous six months.

An instrumented spasticity assessment (hereafter called isolated joint rotations) using the method described by Bar-On and colleagues was performed. Participants lay supine and were asked to relax. The lower leg was supported by a customized frame that allowed ankle rotation. A researcher applied five times a passive rotation of the ankle joint, as fast as possible from a plantar flexed position to the end range of motion towards dorsiflexion.

Reactive balance was tested on a Caren platform. Participants stood barefoot on the platform and were secured with a safety harness. Instructions were to stand upright and maintain balance without stepping unless stepping was necessary to avoid failing. The protocol consisted of six increasingly difficult perturbations levels for the backward translations and four increasingly difficult perturbation levels for the toe-up rotational perturbations. Withing each level, eight perturbations were administered. When participants stepped I more than 3 trials within a level, the participant did not continue to the next level.

Trajectories of reflective skin markers were captured by infrared Vicon Cameras and activity of the lower leg muscles (lateral gastrocnemius, medial gastrocnemius, soleus and tibialis anterior) was measured simultaneously through surface electromyography.

Keywords
spastic cerebral palsy, Reactive balance, muscle co-activation, neurological impairment, Sensorimotor processing, Center of mass feedback, Balance control
Medical subject headings
Cerebral Palsy, Neurologic Manifestations

What participants receive

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

Study groups in NCT07616193
Study groupRoleWhat they receive
Children with cerebral palsyChildren with CP aged between 5 and 17
Typically developing childrenTypically developing children aged between 5 and 17

What is being measured

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

  1. Balance performance

    The number (#) of completed perturbation levels (backward translational and toe-up rotational) without stepping.

    Measured: Cross-sectional data collection at a single time point (baseline measurement).

  2. Maximal horizontal center of mass displacement

    The maximal horizontal Center of Mass (CoM) displacement (cm) is computed in a period of 1.5s following perturbation onset.

    CoM position is computed by consequently applying OpenSim's Inverse Kinematics and Body Kinematics tools with reflective marker trajectories as input. CoM displacement was calculated relative to the ankle.

    Measured: Cross-sectional data collection at a single time point (baseline measurement).

  3. Goodness of fit between predicted and reconstructed muscles activity - R²

    Computational model; Sensorimotor transformations were evaluated by reconstructing measured EMG trajectories (V) by delayed feedback from CoM kinematics.

    EMGrecon=e0+⌊kd∗dCoM(t -τ)+kv∗vCoM(t -τ)+ka∗aCoM(t -τ)+ks

    ∗aCoM Init(t -τ)⌋ with EMG recon = reconstructed muscle activity E0 = baseline muscle activity (during quiet standing) dCoM, vCoM, aCoM = CoM displacement, velocity and acceleration kd, kv, ka = feedbakc gains or weights τ = common time delay of 100 ms

    To test whether CoM feedback can explain reactive muscle activity, the goodness of fit was assessed between predicted and reconstructed muscle activity using the coefficient of determination (r²).

    R² was calculated as the squared correlation coefficient.

    Measured: Cross-sectional data collection at a single time point (baseline measurement)

  4. Goodness of fit between predicted and reconstructed muscles activity - VAF

    Computational model; Sensorimotor transformations were evaluated by reconstructing measured EMG trajectories (V) by delayed feedback from CoM kinematics.

    EMGrecon=e0+⌊kd∗dCoM(t -τ)+kv∗vCoM(t -τ)+ka∗aCoM(t -τ)+ks

    ∗aCoM Init(t -τ)⌋ with EMG recon = reconstructed muscle activity E0 = baseline muscle activity (during quiet standing) dCoM, vCoM, aCoM = CoM displacement, velocity and acceleration kd, kv, ka = feedbakc gains or weights τ = common time delay of 100 ms

    To test whether CoM feedback can explain reactive muscle activity, the goodness of fit was assessed between predicted and reconstructed muscle activity using the Variance Accounted For (VAF).

    VAF was calculated as the uncentered r²

    Measured: Cross-sectional data collection at a single time point (baseline measurement)

  5. Goodness of fit between predicted and reconstructed muscles activity - RMSE

    Computational model; Sensorimotor transformations were evaluated by reconstructing measured EMG trajectories (V) by delayed feedback from CoM kinematics.

    EMGrecon=e0+⌊kd∗dCoM(t -τ)+kv∗vCoM(t -τ)+ka∗aCoM(t -τ)+ks

    ∗aCoM Init(t -τ)⌋ with EMG recon = reconstructed muscle activity E0 = baseline muscle activity (during quiet standing) dCoM, vCoM, aCoM = CoM displacement, velocity and acceleration kd, kv, ka = feedbakc gains or weights τ = common time delay of 100 ms

    To test whether CoM feedback can explain reactive muscle activity, the goodness of fit was assessed between predicted and reconstructed muscle activity using the Root Mean Square Error (RMSE).

    Measured: Cross-sectional data collection at a single time point (baseline measurement)

  6. Sensitiviy of reactive muscle activity to CoM perturbations - gains

    Computational model; Sensorimotor transformations were evaluated by reconstructing measured EMG trajectories (V) by delayed feedback from CoM kinematics.

    EMGrecon=e0+⌊kd∗dCoM(t -τ)+kv∗vCoM(t -τ)+ka∗aCoM(t -τ)+ks

    ∗aCoM Init(t -τ)⌋ with EMG recon = reconstructed muscle activity E0 = baseline muscle activity (during quiet standing) dCoM, vCoM, aCoM = CoM displacement, velocity and acceleration kd, kv, ka = feedbakc gains or weights τ = common time delay of 100 ms

    To test the sensitivity of the reactive muscle activity to the CoM perurbations, the gains (kd,kv,ka) were assessed. Gains indicate the sensitivity of the muscle response to CoM perturbations.

    Measured: Cross-sectional data collection at a single time point (baseline measurement)

  7. Mean reactive muscle activity

    Average reactive muscle activity for

    • lateral gastrocnemius
    • medial gastrocnemius
    • soleus
    • tibialis anterior was computed in three time bins. Reactive muscle activity was calculated by subtracting baseline activity, i.e. average muscle activity in the 100 ms preceding perturbation onset, from the filtered and scaled EMG.

    The first time bin lasted from platform onset to 150 ms after perturbation onset.

    The second time bin lasted from 150 ms to 250 ms after perturbation onset. The third time bin lasted from 250 ms to 400 ms after perturbation onset.

    Measured: Cross-sectional data collection at a single time point (baseline measurement).

  8. Mean center of mass movement

    Average horizontal center of mass movement (cm) was computed in three time bins.

    The first time bin lasted from platform onset to 50 ms after perturbation onset.

    The second time bin lasted from 50 ms to 150 ms after perturbation onset. The third time bin lasted from 150 ms to 300 ms after perturbation onset.

    Measured: Cross-sectional data collection at a single time point (baseline measurement).

  9. Mean ankle kinematics

    Average ankle kinematics (°) was computed in three time bins.

    The first time bin lasted from platform onset to 50 ms after perturbation onset.

    The second time bin lasted from 50 ms to 150 ms after perturbation onset. The third time bin lasted from 150 ms to 300 ms after perturbation onset.

    Measured: Cross-sectional data collection at a single time point (baseline measurement).

  10. Co-Contraction Index (CCI) during translational and rotational perturbations and during isolated joint rotations

    The co-contraction index was calculated as the minimum tibialis anterior and respectively lateral gastrocnemius, medial gastrocnemius and soleus filtered and scaled EMG averaged over the time interval of interest.

    CCI was calculated during backward translational, toe-up rotational perturbations and during isolated joint rotations.

    Measured: Cross-sectional data collection at a single time point (baseline measurement).

Timeline

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

  1. First posted1 Jun 2026
  2. Study start13 Mar 2020
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07616193
Sponsor's protocol ID
S63321
Status last verified
Apr 2026
First submitted
8 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy (CP) and Typically Developing Children, 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance performance (time frame: Cross-sectional data collection at a single time point (baseline measurement).). The study lists 10 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 1 Jun 2026.

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