NCT07616193

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

May 8, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

spastic cerebral palsyReactive balancemuscle co-activationneurological impairmentSensorimotor processingCenter of mass feedbackBalance control

Outcome Measures

Primary Outcomes (10)

  • Balance performance

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

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

  • 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.

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

  • 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.

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

  • 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

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

  • 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).

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Study Arms (2)

Children with cerebral palsy

Children with CP aged between 5 and 17

Typically developing children

Typically developing children aged between 5 and 17

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Aged between 5 and 17 years old
  • Good health
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Cerebral PalsyNeurologic Manifestations

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kaat Desloovere, Prof. dr.

    Department of Rehabilitation Sciences, KU Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 8, 2026

First Posted

June 1, 2026

Study Start

March 13, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

June 1, 2026

Record last verified: 2026-04

Locations