An interventional study of Powered orthosis in Cerebral Palsy (CP), sponsored by IRCCS Eugenio Medea. Recruiting at 6 sites in Italy. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are:
Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy.
Participants will:
Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 40 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Home rehabilitation
Device: Powered orthosis
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Endurance
Distance walked during a 6-minutes walking test (6MWT)
Time frame: Baseline, 3 months and 4 months
Knee extension in mid stance (KEMS)
Anti-gravity knee extension in mid stance measured with quantitative gait analysis
Time frame: Baseline, 3 months and 4 months
Measurements of the Joint range of motions (ROMs) and muscle lengths
Joint Range of motions and muscle lengths as measured by therapists
Time frame: Baseline, 3 months and 4 months
Level of spasticity in the lower limbs
Assessed with the Modified Ashworth scale (MAS)
Time frame: Baseline, 3 months and 4 months
Walking speed
Assessed with the 10-meter walking test (10mWT)
Time frame: Baseline, 3 months and 4 months
Postural and motor abilities
Assessed with the Gross Motor Function Measure-88 (GMFM-88)
Time frame: Baseline, 3 months and 4 months
Gait pattern
Assessed with overground 3D gait analysis with electromyography (EMG) data acquisition
Time frame: Baseline, 3 months and 4 months
Self-perception of performance in everyday living
Assessed with the Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, 3 months and 4 months
Static balance
Assessed with Centre of Pressure (COP) detection using the force platforms of the gait analysis.
Time frame: Baseline, 3 months and 4 months
Usability and acceptability of the powered orthosis
Assessed with the System Usability Scale (SUS) and the Technology Acceptance Method 3 (TAM-3)
Time frame: After the treatment only in the intervention group
Behavioural engagement
Assessed with semi-structured interviews
Time frame: After the treatment only in the intervention group
Spatiotemporal parameters of gait during daily life
Remote monitoring of gait behavior assessed with sensorized shoes
Time frame: Between baseline and month 3
Plan to share: Yes — The results obtained at the end of this clinical trial will be presented at national and international conferences and submitted to peer-reviewed international journals. The raw data of the study will be published among the supplementary materials of scientific articles and/or uploaded to Zenodo, a multidisciplinary repository, managed by CERN in Geneva, which allows researchers to share and preserve research results in any size and form. Depositing data in ZENODO guarantees their compliance with the FAIR principles.
Supporting information: Study protocol, Statistical analysis plan
Started Oct 2024 (actual). Primary completion is estimated for Nov 2026, 25 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 25 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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