Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Agilik@home
Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
2 other identifiers
interventional
40
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 2, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
April 6, 2025
April 1, 2025
1.7 years
September 30, 2024
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Endurance
Distance walked during a 6-minutes walking test (6MWT)
Baseline, 3 months and 4 months
Knee extension in mid stance (KEMS)
Anti-gravity knee extension in mid stance measured with quantitative gait analysis
Baseline, 3 months and 4 months
Secondary Outcomes (9)
Measurements of the Joint range of motions (ROMs) and muscle lengths
Baseline, 3 months and 4 months
Level of spasticity in the lower limbs
Baseline, 3 months and 4 months
Walking speed
Baseline, 3 months and 4 months
Postural and motor abilities
Baseline, 3 months and 4 months
Gait pattern
Baseline, 3 months and 4 months
- +4 more secondary outcomes
Other Outcomes (1)
Spatiotemporal parameters of gait during daily life
Between baseline and month 3
Study Arms (2)
Intervention Arm
EXPERIMENTALHome rehabilitation
Control Group
NO INTERVENTIONInterventions
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Eligibility Criteria
You may qualify if:
- Diagnosis of CP and a crouch gait
- 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
You may not qualify if:
- Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk;
- A history of uncontrolled seizure in the past year
- Severe spasticity
- Hip and/or knee flexion contracture of more than 20°
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IRCCS Eugenio Medealead
- IRCCS Fondazione Stella Mariscollaborator
- Fondazione Don Carlo Gnocchi Onluscollaborator
- Fondazione Mondinocollaborator
Study Sites (6)
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Lecco, 23842, Italy
IRCCS Fondazione Stella Maris
Calambrone, Pisa, 56128, Italy
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan, 20148, Italy
Fondazione Mondino
Pavia, 27100, Italy
Fondazione Don Carlo Gnocchi Onlus
Roma, 00194, Italy
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Salerno, 84131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 2, 2024
Study Start
October 29, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
April 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
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.