Home Use of Agilik Powered Orthosis to Improve Walking and Endurance in Children with Cerebral Palsy
Led by IRCCS Eugenio Medea · Updated on 2026-06-26
40
Participants Needed
6
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate whether using the Agilik powered orthosis for two months can improve knee extension and endurance in children with Cerebral Palsy who have a crouch gait. It also seeks to understand the safety of the Agilik device. The study compares children using the Agilik powered exoskeleton at home with those receiving standard therapy to see if the device helps with walking ability.
Participants in the intervention group will use the Agilik orthosis at home for two months, practicing walking with the device for 30 minutes a day, five days a week. The control group will undergo standard therapy. The study includes visits to a clinic at the start, after three months, and again one month later to assess progress and safety.
During the study, researchers will measure endurance and knee extension during walking at the beginning, after three months, and after four months. They will also assess joint range of motion, muscle length, spasticity, walking speed, posture, motor abilities, gait pattern, self-perceived performance in daily life, and balance. For those using the Agilik device, usability, acceptability, and behavioral engagement will be evaluated after treatment. Participants are monitored over several months with clinic visits to understand outcomes and safety.
CONDITIONS
Brief Title
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Research Team
E
Emilia Biffi, PhD
C
Cristina Maghini, MD
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Willingness and ability to comply with all study procedures and availability for the study duration
Body weight between 20 and 125 kilograms
Knee flexion retraction less than 10 degrees in supine position
No tibio-tarsal arthrodesis and at least 5 degrees of passive ankle dorsiflexion
Able to walk at least 3 meters without stopping, with or without walking aid
Able to understand and follow simple directions
GMFCS level I, II, or III
Modified Ashworth Scale (MAS) score less than or equal to 2
You will not qualify if you...
Severe neurological, musculoskeletal, or cardiorespiratory conditions preventing walking
History of uncontrolled seizures in the past year
Severe spasticity
Hip or knee flexion contracture greater than 20 degrees
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 2 months
Participants use the Agilik powered orthosis at home for 2 months, practicing walking 30 minutes per day, 5 days per week, or receive standard therapy.
Clinic visits at baseline, 3 months, and 4 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Agilik@home: A randomized controlled trial protocol to evaluate the effects of home-based training with the Agilik powered KAFO in children with cerebral palsy and crouch gait.
Roberta Nossa, Fabio Alexander Storm, Eleonora Diella...