CompletedNot Applicable

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

Belgium40 participantsStarted 2020-03-13

Plain-language 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.

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Children with CP: Inclusion Criteria: * 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 Exclusion Criteria: * 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: Inclusion criteria: * Aged between 5 and 17 years old * Good health Exclusion criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Balance performance

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

Maximal horizontal center of mass displacement

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

Goodness of fit between predicted and reconstructed muscles activity - R²

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

Goodness of fit between predicted and reconstructed muscles activity - VAF

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

Goodness of fit between predicted and reconstructed muscles activity - RMSE

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

Sensitiviy of reactive muscle activity to CoM perturbations - gains

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

Trial details

NCT IDNCT07616193

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-08-30

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials