NCT07818928

Brief Summary

The aim of this project was to evaluate whether perturbation training influences reflex modulation in children with spastic CP and whether changed reflex modulation leads to improved reactive balance and walking. Reactive balance was trained using rotational perturbations. Reactive balance performance and reactive muscle activity during trained and untrained perturbation conditions were assessed in children with cerebral palsy and typically developing children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

4.1 years

First QC Date

September 8, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Spastic cerebral palsyReactive balancePerturbation trainingBalance performancemuscle co-activation

Outcome Measures

Primary Outcomes (2)

  • Balance performance

    Balance performance was evaluated as the number of levels the participant was able to complete before and after training. A level was considered successful if the participant was able to maintain balance without stepping in at least five out of eight trials.

    Baseline and after finishing the nine training sessions (3 weeks)

  • Co-contraction index

    The co-contraction index (CCI), a measure of muscle co-activation, was computed as the common area below tibialis anterior and respectively lateral gastrocnemius, medial gastrocnemius, and soleus filtered and scaled EMG trajectories averaged over time (equation 1) during rotational and translational perturbations of standing balance. CCI = (∑〖min⁡(〖EMG\_PF,〖EMG\_TA)〗)/(# frames) (Equation 1) with PF referring to lateral gastrocnemius, medial gastrocnemius, or soleus; and # frames the number of data points in the analyzed time interval. The CCI was calculated for each trial over an interval from 0.5s before perturbation onset until 1.5s after perturbation onset. Trials where the participant took a step were excluded. The average CCI across all non-stepping trials was calculated for each level.

    Baseline and after finishing the nine training sessions (3 weeks)

Secondary Outcomes (1)

  • Average muscle activity within three time zones

    Baseline and after finishing the nine training sessions (3 weeks)

Study Arms (1)

Perturbation training

EXPERIMENTAL

Perturbation training

Other: Balance training on a moving platform

Interventions

The training intervention consisted of nine sessions (spread over 3 weeks), which took about 30 minutes each. The first and last session immediately followed and preceded respectively the pre- and post-intervention assessments. During one session, three identical blocks of 32 toe-up rotational perturbations were administered. Each block consisted of perturbations with two different difficulty levels (16 trials each). The administered perturbation levels were selected based on the participant's performance in the previous training session (for training sessions two to nine) and pre-intervention assessment (for the first training session). If the participant was able to maintain balance without stepping in at least 80% of the trials, a more difficult level was offered in the next training. When the participant was able to perform all levels, the training was continued by combining both lower and higher levels, in order to train the complete range of perturbation levels.

Perturbation training

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of cerebral plasy
  • Spasticity as defined by a clinical assessment, in the gastrocnemius muscle
  • Aged 5-17 years old
  • GMFCS level 1-2

You may not qualify if:

  • Presence of ataxia or dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities
  • Irritated skin or open wounds where sensors will be placed
  • Botox or surgery in the lower limbs in the last six months
  • Not be able to stand or walk independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kaat Desloovere, Prof. dr.

    Department of Rehabilitation Sciences, KU Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Both groups (CP and TD) followed the perturbation training (3 weeks - 9 sessions)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

July 26, 2021

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

September 15, 2026

Record last verified: 2026-09

Locations