Actively Recruiting
Led by IRCCS Eugenio Medea · Updated on 2025-04-06
40
Participants Needed
6
Research Sites
N/A
Total Duration
I
IRCCS Eugenio Medea
Lead Sponsor
I
IRCCS Fondazione Stella Maris
Collaborating Sponsor
Researchers are evaluating whether using the Agilik powered orthosis for two months improves knee extension and endurance in children aged 5 to 17 with Cerebral Palsy who have a crouch gait. The study also aims to assess the safety of this device compared to standard therapy. Participants are divided into groups to compare effects between those using the Agilik orthosis and those receiving usual care. Participants in the intervention group will use the Agilik powered orthosis at home for 30 minutes a day, five days a week, over two months to practice walking. The control group will follow standard therapy without the device. The trial includes visits to the clinic at the start, after three months, and one month later to monitor progress and collect data. Throughout the study, participants will undergo assessments of endurance and knee extension during walking at baseline, three months, and four months. Additional measures include joint range of motion, muscle lengths, spasticity levels, walking speed, posture and motor skills, gait patterns, self-perceived daily performance, and balance. For those using the device, usability and engagement will also be evaluated after treatment. The total participation lasts about four months with regular follow-ups to monitor safety and effectiveness.
CONDITIONS
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 months
Participants in the intervention group use the powered orthosis at home for rehabilitation, practicing walking with the device for 30 minutes a day, 5 days a week, over 2 months.
Home use with daily practice, no required visits during treatment
Duration - 4 months
Participants undergo assessments to measure endurance, knee extension, joint range of motion, spasticity, walking speed, motor abilities, gait pattern, self-perception, and static balance at baseline, 3 months, and 4 months. The intervention group also evaluates usability and behavioural engagement after treatment.
3 visits at Baseline, Month 3, and Month 4
Total: 6 locations
1
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Lecco, Italy, 23842
Actively Recruiting
2
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy, 56128
Not Yet Recruiting
3
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan, Italy, 20148
Actively Recruiting
4
Fondazione Mondino
Pavia, Italy, 27100
Not Yet Recruiting
5
Fondazione Don Carlo Gnocchi Onlus
Roma, Italy, 00194
Actively Recruiting
6
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Salerno, Italy, 84131
Actively Recruiting
E
Emilia Biffi, PhD
C
Cristina Maghini, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Roberta Nossa, Fabio Alexander Storm, Eleonora Diella...
https://pubmed.ncbi.nlm.nih.gov/41880375