Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
NCT ID: NCT06622655
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-10-29
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm
Home rehabilitation
Powered orthosis
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Control Group
No interventions assigned to this group
Interventions
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Powered orthosis
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Eligibility Criteria
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Inclusion Criteria
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
* Body weight between 20 and 125 Kg
* Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
* Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle.
* Able to walk at least 3 m without stopping, with or without a walking aid.
* Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination.
* GMFCS level I, II and III
* MAS score ≤ 2
Exclusion Criteria
* A history of uncontrolled seizure in the past year
* Severe spasticity
* Hip and/or knee flexion contracture of more than 20°
5 Years
17 Years
ALL
No
Sponsors
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IRCCS Fondazione Stella Maris
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Fondazione Mondino
OTHER
IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Lecco, Italy
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan, , Italy
Fondazione Mondino
Pavia, , Italy
Fondazione Don Carlo Gnocchi Onlus
Roma, , Italy
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Salerno, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PNC0000007
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GIP1122
Identifier Type: -
Identifier Source: org_study_id
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