Cerebral PalsyAgilikNCT05746871
Safety and Performance of Agilik in CP
A study testing Agilik in people with Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Agilik
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
- Age between 5 and 17
- Maximum weight of 70 Kg
- Volunteer who have a gait pathology involving the knee joint, from a diagnosis of CP
- 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.
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- Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 10° 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 history and physical examination.
- GMFCS level I, II and III
- MAS score ≤ 2
Who cannot join
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
- A history of uncontrolled seizure in the past year
- Severe spasticity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market Study to Demonstrate the Safety and Performance of an Extension Assist Knee Ankle Foot Orthosis (Agilik) to Improve Gait in Children With Cerebral Palsy
The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral palsy (CP). The EA-KAFO tested in this investigation, whose commercial name is Agilik™, is registered as a Class 1 medical device in the European (EU) Medical Device Regulation (MDR) and with the United States (US) Food and Drugs Administration (FDA). The study will take place in Astrolab at the Istituto Scientifico E. MEDEA - La Nostra Famiglia (IRCCS Medea hereafter). The duration of the investigation will be 36 months. The duration of the study for a single subject will be approximately 10 weeks.
The primary purpose of this study is to demonstrate the safety and performance of a powered extension assist knee ankle foot orthosis (Agilik) in individuals with knee extension deficiency due to cerebral palsy. The focus is on the improvement of anti-gravity knee extension during stance in patients with CP with crouch gait. Therefore, the primary aim is to compare the knee and range of motion (ROM) at baseline and after 10 sessions of Agilik training while wearing Agilik itself. Secondary aim is to compare knee ROM before and after the training with Agilik without wearing Agilik.
Read more
The changes in lower extremity functions, kinematics and muscle activity during walking with Agilik compared to baseline conditions will be examined. Furthermore, the performance of Agilik during uphill and downhill walking over the GRAIL platform will be investigated.
Hypotheses when using Agilik:
- Improve knee extension during stance and swing gait phases
- Increase step length, walking distance and speed
- Conditions
- Cerebral Palsy
- Being tested
- Agilik, standard care
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgilikDevice
The Agilik is a powered orthosis system that can assist or resist motion independently in each gait phase. It is used as a pair of knee-ankle-foot orthosis (KAFO), one for each leg. The device applies up to 12 Nm across the knee in the direction of either flexion or extension. The system consists of an orthosis for each leg integrated with an electro-mechanical actuator, a battery, a carry pack, cabling and application software running on a computer. A foot pressure sensor is embedded in the footbed of the KAFO and connected to the actuator. The foot sensor and angular velocity are used to detect the gait phase of the patient and communicate with the motor controller to provide a unique torque for each gait phase. The torque ramp and intensity can be modified through the Agilik App to cater towards individual patients by assisting or resisting motion during their gait. This allows for the clinician working with the patient to adjust the settings of the device for the patient's needs.
standard careOther
Subjects will continue with their standard care for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| GroupA_Agilik first | Experimental | This arm will be assessed at T0, then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and will perform T1 evaluations, and then it will repeat the evaluations after other 5 weeks (T2) during which they performed they standard care Receives: Device: Agilik; Other: standard care |
| GroupB_standard care first | Experimental | This arm will be assessed at T0, then it will continue with their standard care and will perform T1 evaluation after 5 weeks, and then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and the final evaluation (T2) Receives: Device: Agilik; Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of range of motion of the knee overground
the range of motion of the knee will be measured by means of BTS Bioengineering S.p.A. optoelectronic system during the overground gait analysis assessment with Agilik
Measured: 6 weeks
change of range of motion of the knee uphill/downhill
the range of motion of the knee will be measured by means of the GRAILoptoelectronic system that is equipped with a motion platform and that will simulate uphill and downhill walking while performing gait analysis assessment with Agilik
Measured: 6 weeks
change in endurance
The endurance will be measured by means of the 6 minute walking test (6MWT) with Agilik
Measured: 6 weeks
change in gait speed
the gait speed will be measured by means of the 10 meters walking test (10mWT) with Agilik
Measured: 6 weeks
change in spasticity
The level of spasticity in the lower limbs will be measured by means of the Ashworth scale (MAS level, Modified Ashworth scale level) with Agilik
Measured: 6 weeks
change in muscle lengths
Joint and muscle lengths examination will be performed manually
Measured: 6 weeks
change in centre of pressure oscillations
Centre of pressure (COP) oscillations will be assessed by means of the force plates embedded in the GRAIL system, during 1 minute of still standing
Measured: 6 weeks
change in centre of mass oscillations
Centre of mass (COM) oscillations will be measured during 1 minute of standing by means of the G-Sensor, a wearable three axial accelerometer and gyroscope
Measured: 6 weeks
satisfaction using Agilik
the children's satisfaction with Agilik will be evaluated with the Quebec User Evaluation of Satisfaction adapted to children (QUEST 2.1).
Measured: 6 weeks
Secondary outcomes (6)
change of range of motion of the knee overground without Agilik
the range of motion of the knee will be measured by means of BTS Bioengineering S.p.A. optoelectronic system during the overground gait analysis assessment without Agilik
Measured: 6 weeks
change of range of motion of the knee uphill/downhill without Agilik
the range of motion of the knee will be measured by means of the GRAILoptoelectronic system that is equipped with a motion platform and that will simulate uphill and downhill walking while performing gait analysis assessment without Agilik
Measured: 6 weeks
change in endurance without Agilik
The endurance will be measured by means of the 6 minute walking test (6MWT) without Agilik
Measured: 6 weeks
change in gait speed without Agilik
the gait speed will be measured by means of the 10 meters walking test (10mWT) without Agilik
Measured: 6 weeks
change in centre of pressure oscillations without Agilik
Centre of pressure (COP) oscillations will be assessed by means of the force plates embedded in the GRAIL system, during 1 minute of still standing without Agilik
Measured: 6 weeks
change in centre of mass oscillations without Agilik
Centre of mass (COM) oscillations will be measured during 1 minute of standing without Agilik by means of the G-Sensor, a wearable three axial accelerometer and gyroscope
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start2 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: The study was discontinued after the expiration of Ethics Committee approval, as the required conditions to continue the trial were no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Ro+Ten srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746871
- Sponsor's protocol ID
- GIP1030
- Acronym
- Agilik
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study to Demonstrate the Safety and Performance of an Extension Assist Knee Ankle Foot Orthosis (Agilik) to Improve Gait in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05746871
- Acronym / sponsor ID
- Agilik / GIP1030
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued after the expiration of Ethics Committee approval, as the required conditions to continue the trial were no longer available.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Ro+Ten srl
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Feb 2023 (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 purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral palsy (CP). The EA-KAFO tested in this investigation, whose commercial name is Agilik™, is registered as a Class 1 medical device in the European (EU) Medical Device Regulation (MDR) and with the United States (US) Food and Drugs Administration (FDA). The study will take place in Astrolab at the Istituto Scientifico E. MEDEA - La Nostra Famiglia (IRCCS Medea hereafter). The duration of the investigation will be 36 months. The duration of the study for a single subject will be approximately 10 weeks.
The primary purpose of this study is to demonstrate the safety and performance of a powered extension assist knee ankle foot orthosis (Agilik) in individuals with knee extension deficiency due to cerebral palsy. The focus is on the improvement of anti-gravity knee extension during stance in patients with CP with crouch gait. Therefore, the primary aim is to compare the knee and range of motion (ROM) at baseline and after 10 sessions of Agilik training while wearing Agilik itself. Secondary aim is to compare knee ROM before and after the training with Agilik without wearing Agilik.
The changes in lower extremity functions, kinematics and muscle activity during walking with Agilik compared to baseline conditions will be examined. Furthermore, the performance of Agilik during uphill and downhill walking over the GRAIL platform will be investigated.
Hypotheses when using Agilik:
- Improve knee extension during stance and swing gait phases
- Increase step length, walking distance and speed
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupA_Agilik first | Experimental | Device: Agilik, Other: standard careThis arm will be assessed at T0, then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and will perform T1 evaluations, and then it will repeat the evaluations after other 5 weeks (T2) during which they performed they standard care |
| GroupB_standard care first | Experimental | Device: Agilik, Other: standard careThis arm will be assessed at T0, then it will continue with their standard care and will perform T1 evaluation after 5 weeks, and then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and the final evaluation (T2) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
- Age between 5 and 17
- Maximum weight of 70 Kg
- Volunteer who have a gait pathology involving the knee joint, from a diagnosis of CP
Key exclusion criteria (3 listed)
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
- A history of uncontrolled seizure in the past year
- Severe spasticity
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 |
|---|---|---|
| AgilikThe Agilik is a powered orthosis system that can assist or resist motion independently in each gait phase. It is used as a pair of knee-ankle-foot orthosis (KAFO), one for each leg. The device applies up to 12 Nm across the knee in the direction of either flexion or extension. The system consists of an orthosis for each leg integrated with an electro-mechanical actuator, a battery, a carry pack, cabling and application software running on a computer. A foot pressure sensor is embedded in the footbed of the KAFO and connected to the actuator. The foot sensor and angular velocity are used to detect the gait phase of the patient and communicate with the motor controller to provide a unique torque for each gait phase. The torque ramp and intensity can be modified through the Agilik App to cater towards individual patients by assisting or resisting motion during their gait. This allows for the clinician working with the patient to adjust the settings of the device for the patient's needs. | Device | GroupA_Agilik first, GroupB_standard care first |
| standard careSubjects will continue with their standard care for 5 weeks | Other | GroupA_Agilik first, GroupB_standard care first |
Primary outcome
change of range of motion of the knee overground
Time frame: 6 weeks
the range of motion of the knee will be measured by means of BTS Bioengineering S.p.A. optoelectronic system during the overground gait analysis assessment with Agilik
change of range of motion of the knee uphill/downhill
Time frame: 6 weeks
the range of motion of the knee will be measured by means of the GRAILoptoelectronic system that is equipped with a motion platform and that will simulate uphill and downhill walking while performing gait analysis assessment with Agilik
change in endurance
Time frame: 6 weeks
The endurance will be measured by means of the 6 minute walking test (6MWT) with Agilik
change in gait speed
Time frame: 6 weeks
the gait speed will be measured by means of the 10 meters walking test (10mWT) with Agilik
change in spasticity
Time frame: 6 weeks
The level of spasticity in the lower limbs will be measured by means of the Ashworth scale (MAS level, Modified Ashworth scale level) with Agilik
change in muscle lengths
Time frame: 6 weeks
Joint and muscle lengths examination will be performed manually
change in centre of pressure oscillations
Time frame: 6 weeks
Centre of pressure (COP) oscillations will be assessed by means of the force plates embedded in the GRAIL system, during 1 minute of still standing
change in centre of mass oscillations
Time frame: 6 weeks
Centre of mass (COM) oscillations will be measured during 1 minute of standing by means of the G-Sensor, a wearable three axial accelerometer and gyroscope
satisfaction using Agilik
Time frame: 6 weeks
the children's satisfaction with Agilik will be evaluated with the Quebec User Evaluation of Satisfaction adapted to children (QUEST 2.1).
6 secondary outcomes
change of range of motion of the knee overground without Agilik
Time frame: 6 weeks
change of range of motion of the knee uphill/downhill without Agilik
Time frame: 6 weeks
change in endurance without Agilik
Time frame: 6 weeks
change in gait speed without Agilik
Time frame: 6 weeks
change in centre of pressure oscillations without Agilik
Time frame: 6 weeks
change in centre of mass oscillations without Agilik
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: The study was discontinued after the expiration of Ethics Committee approval, as the required conditions to continue the trial were no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agilik in people with Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site 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 11 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The study was discontinued after the expiration of Ethics Committee approval, as the required conditions to continue the trial were no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of range of motion of the knee overground (time frame: 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026.