Cerebral Palsy (CP)NCT07818928
The Effect of Perturbation Training on Reactive Balance in Children With Cerebral Palsy
A study testing Balance training on a moving platform in people with Cerebral Palsy (CP) and Typically Developing Children, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP), Typically Developing Children
- What is being tested?
- Balance training on a moving platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jul 2021to 29 Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of cerebral plasy
- Spasticity as defined by a clinical assessment, in the gastrocnemius muscle
- Aged 5-17 years old
- GMFCS level 1-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perturbation Training on Reflex Modulation, Reactive Balance and Walking in Children With Spastic Cerebral Palsy.
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.
Read the detailed description
Background:
With an incidence of 2 to 3 per 1000 live births, cerebral palsy (CP) is the most common cause of physical disability in children. CP is caused by a non-progressive lesion to the developing brain. The resulting inability to selectively control muscles, spasticity, and muscle weakness undermine the child's mobility and balance. Spasticity is the most common impairment in CP and is clinically characterized by increased resistance to imposed stretch to the muscle. During clinical tests of spasticity, muscles are stretched with the purpose of assessing resistance. Yet, similar stretches occur on a daily basis when balance during standing or walking is perturbed (e.g. standing on a departing bus or walking on uneven terrain). Therefore, spasticity might contribute to balance impairments that are common in CP.
When standing balance is perturbed, intrinsic mechanical properties depending on muscle tone (> 0ms), spinal reflexes leading to small changes in muscle activity (> 50ms), and balance correcting changes (>100-120ms after onset) contribute to restoring posture with different delays. The effectiveness of those mechanisms will depend on the ability to modulate muscle tone and reflex gains. Children with CP have increased muscle tone and reflex hyper-excitability, which might contribute to decreased balance capacities. Furthermore, the ability to modulate reflex activity is decreased in children with spastic CP compared to healthy children.
This might explain why children with CP respond differently to a perturbation of standing balance than typically developing (TD) children. For instance, children with CP adopt a hip strategy at lower perturbation magnitudes than TD children. However, there is evidence that spinal reflexes can be trained in both healthy individuals and individuals with neurological disorders and that such reflex conditioning improves function, such as walking. Perturbation training has been shown to improve balance in children with CP . However, the underlying mechanisms of these improvements are not well understood. Therefore, 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.
Methods:
An intervention study was performed in which children with spastic CP followed perturbation training during a 3-week period. The training consists of 9 sessions (3 sessions/week) of 30 minutes. During these sessions, balance will be trained using rotational perturbations with different magnitudes. The participant is asked to maintain balance without stepping and stay as upright as possible. Difficulty level will increase every training adapted to the subject.
Before and after training, the response to muscle stretches, reactive balance (strategies) and walking performance was assessed.
During the pre- and post-measurement sessions, kinematics (joint angles), ground reaction forces (GRFs) and muscle activity (electromyography, EMG) were recorded.
- Conditions
- Cerebral Palsy (CP), Typically Developing Children
- Being tested
- Balance training on a moving platform
- Keywords
- Spastic cerebral palsy, Reactive balance, Perturbation training, Balance performance, muscle co-activation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance training on a moving platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation training | Experimental | Perturbation training Receives: Other: Balance training on a moving platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and after finishing the nine training sessions (3 weeks)
Secondary outcomes (1)
Average muscle activity within three time zones
Average muscle activity was compute for lateral and medial gastrocnemius, soleus, and tibialis anterior in three time bins during rotational and translational perturbations of standing balance. Reactive muscle activity within each time bin was computed as the average filtered and scaled EMG within the time bin from which baseline activity (average EMG during 100ms preceding perturbation onset) was subtracted. The first time bin started at platform onset and ended 150 ms later. The second time bin lasted from 150 ms to 250 ms after platform onset. The third time bin (Z3) lasted from 250 ms to 400 ms after perturbation onset.
Measured: Baseline and after finishing the nine training sessions (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start26 Jul 2021
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Both groups (CP and TD) followed the perturbation training (3 weeks - 9 sessions)
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kaat Desloovere, Prof. dr., Principal investigator, Department of Rehabilitation Sciences, KU Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818928
- Sponsor's protocol ID
- S65672
- Other IDs
- 1192320N
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perturbation Training on Reflex Modulation, Reactive Balance and Walking in Children With Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT07818928
- Acronym / sponsor ID
- S65672
- Conditions
- Cerebral Palsy (CP), Typically Developing Children
- Keywords
- Spastic cerebral palsy, Reactive balance, Perturbation training, Balance performance, muscle co-activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
With an incidence of 2 to 3 per 1000 live births, cerebral palsy (CP) is the most common cause of physical disability in children. CP is caused by a non-progressive lesion to the developing brain. The resulting inability to selectively control muscles, spasticity, and muscle weakness undermine the child's mobility and balance. Spasticity is the most common impairment in CP and is clinically characterized by increased resistance to imposed stretch to the muscle. During clinical tests of spasticity, muscles are stretched with the purpose of assessing resistance. Yet, similar stretches occur on a daily basis when balance during standing or walking is perturbed (e.g. standing on a departing bus or walking on uneven terrain). Therefore, spasticity might contribute to balance impairments that are common in CP.
When standing balance is perturbed, intrinsic mechanical properties depending on muscle tone (> 0ms), spinal reflexes leading to small changes in muscle activity (> 50ms), and balance correcting changes (>100-120ms after onset) contribute to restoring posture with different delays. The effectiveness of those mechanisms will depend on the ability to modulate muscle tone and reflex gains. Children with CP have increased muscle tone and reflex hyper-excitability, which might contribute to decreased balance capacities. Furthermore, the ability to modulate reflex activity is decreased in children with spastic CP compared to healthy children.
This might explain why children with CP respond differently to a perturbation of standing balance than typically developing (TD) children. For instance, children with CP adopt a hip strategy at lower perturbation magnitudes than TD children. However, there is evidence that spinal reflexes can be trained in both healthy individuals and individuals with neurological disorders and that such reflex conditioning improves function, such as walking. Perturbation training has been shown to improve balance in children with CP . However, the underlying mechanisms of these improvements are not well understood. Therefore, 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.
Methods:
An intervention study was performed in which children with spastic CP followed perturbation training during a 3-week period. The training consists of 9 sessions (3 sessions/week) of 30 minutes. During these sessions, balance will be trained using rotational perturbations with different magnitudes. The participant is asked to maintain balance without stepping and stay as upright as possible. Difficulty level will increase every training adapted to the subject.
Before and after training, the response to muscle stretches, reactive balance (strategies) and walking performance was assessed.
During the pre- and post-measurement sessions, kinematics (joint angles), ground reaction forces (GRFs) and muscle activity (electromyography, EMG) were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Both groups (CP and TD) followed the perturbation training (3 weeks - 9 sessions)
| Arm | Type | Receives |
|---|---|---|
| Perturbation training | Experimental | Other: Balance training on a moving platformPerturbation training |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of cerebral plasy
- Spasticity as defined by a clinical assessment, in the gastrocnemius muscle
- Aged 5-17 years old
- GMFCS level 1-2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance training on a moving platformThe 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. | Other | Perturbation training |
Primary outcome
Balance performance
Time frame: Baseline and after finishing the nine training sessions (3 weeks)
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.
Co-contraction index
Time frame: Baseline and after finishing the nine training sessions (3 weeks)
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.
1 secondary outcome
Average muscle activity within three time zones
Time frame: Baseline and after finishing the nine training sessions (3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaat Desloovere, Prof. dr. principal investigator
Department of Rehabilitation Sciences, KU Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training on a moving platform in people with 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 4 inclusion and 6 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 15 Sep 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: Baseline and after finishing the nine training sessions (3 weeks)). The study lists 2 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 15 Sep 2026.