Cerebral Palsy (CP)Agilik@homeNCT06622655
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
A study testing Powered orthosis in people with Cerebral Palsy (CP), run by IRCCS Eugenio Medea at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Powered orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesItaly
- Study dates
- 29 Oct 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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°
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Maghini, MD contact
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Lecco, 23842
Emilia Biffi, PhD, +39031877862, emilia.biffi@lanostrafamiglia.it
Cristina Maghini, MD, cristina.maghini@lanostrafamiglia.it
- Not yet recruiting
IRCCS Fondazione Stella Maris
Calambrone, Pisa, 56128
Giuseppina Sgandurra, MD, PhD, +39050886284, giuseppina.sgandurra@fsm.unipi.it
- Recruiting
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan, 20148
Angela Cavalagli, MD, +3902403081, acavalagli@dongnocchi.it
- Not yet recruiting
Fondazione Mondino
Pavia, 27100
Sabrina Signorini, MD, +3903823801, sabrina.signorini@mondino.it
- Recruiting
Fondazione Don Carlo Gnocchi Onlus
Roma, 00194
Laura Iuvone, MD, +3906330861, liuvone@dongnocchi.it
- Recruiting
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Salerno, 84131
Irene Aprile, MD, PhD, +39089334425, iaprile@dongnocchi.it
About this study
Official title: Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
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.
Read more
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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Powered orthosis
- Keywords
- exoskeleton device, powered orthosis, cerebral palsy, crouch gait, home use
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered orthosisDevice
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Home rehabilitation Receives: Device: Powered orthosis |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance
Distance walked during a 6-minutes walking test (6MWT)
Measured: Baseline, 3 months and 4 months
Knee extension in mid stance (KEMS)
Anti-gravity knee extension in mid stance measured with quantitative gait analysis
Measured: Baseline, 3 months and 4 months
Secondary outcomes (9)
Measurements of the Joint range of motions (ROMs) and muscle lengths
Joint Range of motions and muscle lengths as measured by therapists
Measured: Baseline, 3 months and 4 months
Level of spasticity in the lower limbs
Assessed with the Modified Ashworth scale (MAS)
Measured: Baseline, 3 months and 4 months
Walking speed
Assessed with the 10-meter walking test (10mWT)
Measured: Baseline, 3 months and 4 months
Postural and motor abilities
Assessed with the Gross Motor Function Measure-88 (GMFM-88)
Measured: Baseline, 3 months and 4 months
Gait pattern
Assessed with overground 3D gait analysis with electromyography (EMG) data acquisition
Measured: Baseline, 3 months and 4 months
Self-perception of performance in everyday living
Assessed with the Canadian Occupational Performance Measure (COPM)
Measured: Baseline, 3 months and 4 months
Static balance
Assessed with Centre of Pressure (COP) detection using the force platforms of the gait analysis.
Measured: 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)
Measured: After the treatment only in the intervention group
Behavioural engagement
Assessed with semi-structured interviews
Measured: After the treatment only in the intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start29 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris, Fondazione Don Carlo Gnocchi ETS, IRCCS National Neurological Institute "C. Mondino" Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622655
- Sponsor's protocol ID
- GIP1122
- Other IDs
- PNC0000007
- Acronym
- Agilik@home
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Nossa R, Storm FA, Diella E, Riboni R, Molteni LE, Chiappini M, Maghini C, Beretta E, Nicotra R, Abbondio S, Ferrante C, Cotardo A, Sgherri G, Germanotta M, Mauro MC, Fasano A, Cordoni C, Ferrarin M, Cavallini A, Signorini SG, Sgandurra G, Aprile I, Iuvone L, Cavalagli A, Biffi E; Agilik@home Study Group. 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. PLoS One. 2026 Mar 25;21(3):e0340877. doi: 10.1371/journal.pone.0340877. eCollection 2026.
PubMed 41880375
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06622655
- Acronym / sponsor ID
- Agilik@home / GIP1122
- Conditions
- Cerebral Palsy (CP)
- Keywords
- exoskeleton device, powered orthosis, cerebral palsy, crouch gait, home use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris, Fondazione Don Carlo Gnocchi ETS, IRCCS National Neurological Institute "C. Mondino" Foundation
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Powered orthosisHome rehabilitation |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered orthosisHome rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home. | Device | Intervention Arm |
Primary outcome
Endurance
Time frame: Baseline, 3 months and 4 months
Distance walked during a 6-minutes walking test (6MWT)
Knee extension in mid stance (KEMS)
Time frame: Baseline, 3 months and 4 months
Anti-gravity knee extension in mid stance measured with quantitative gait analysis
9 secondary outcomes
Measurements of the Joint range of motions (ROMs) and muscle lengths
Time frame: Baseline, 3 months and 4 months
Level of spasticity in the lower limbs
Time frame: Baseline, 3 months and 4 months
Walking speed
Time frame: Baseline, 3 months and 4 months
Postural and motor abilities
Time frame: Baseline, 3 months and 4 months
Gait pattern
Time frame: Baseline, 3 months and 4 months
Self-perception of performance in everyday living
Time frame: Baseline, 3 months and 4 months
Static balance
Time frame: Baseline, 3 months and 4 months
Usability and acceptability of the powered orthosis
Time frame: After the treatment only in the intervention group
Behavioural engagement
Time frame: After the treatment only in the intervention group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 41880375Nossa R, Storm FA, Diella E, Riboni R, Molteni LE, Chiappini M, Maghini C, Beretta E, Nicotra R, Abbondio S, Ferrante C, Cotardo A, Sgherri G, Germanotta M, Mauro MC, Fasano A, Cordoni C, Ferrarin M, Cavallini A, Signorini SG, Sgandurra G, Aprile I, Iuvone L, Cavalagli A, Biffi E; Agilik@home Study Group. 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. PLoS One. 2026 Mar 25;21(3):e0340877. doi: 10.1371/journal.pone.0340877. eCollection 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Maghini, MD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered orthosis in people with Cerebral Palsy (CP), run by IRCCS Eugenio Medea at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilia Biffi, PhD (+39031877862, emilia.biffi@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance (time frame: Baseline, 3 months and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.