Clinical trial NCT05746871: Safety and Performance of Agilik in CP
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: Ro+Ten srl
First posted: 2023-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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


Eligibility criteria: 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.
* 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.
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change of range of motion of the knee overground
timeFrame: 6 weeks
measure: change of range of motion of the knee uphill/downhill
timeFrame: 6 weeks
measure: change in endurance
timeFrame: 6 weeks
measure: change in gait speed
timeFrame: 6 weeks
measure: change in spasticity
timeFrame: 6 weeks
measure: change in muscle lengths
timeFrame: 6 weeks
measure: change in centre of pressure oscillations
timeFrame: 6 weeks
measure: change in centre of mass oscillations
timeFrame: 6 weeks
measure: satisfaction using Agilik
timeFrame: 6 weeks
Secondary outcomes:
measure: change of range of motion of the knee overground without Agilik
timeFrame: 6 weeks
measure: change of range of motion of the knee uphill/downhill without Agilik
timeFrame: 6 weeks
measure: change in endurance without Agilik
timeFrame: 6 weeks
measure: change in gait speed without Agilik
timeFrame: 6 weeks
measure: change in centre of pressure oscillations without Agilik
timeFrame: 6 weeks
measure: change in centre of mass oscillations without Agilik
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Medea
Study officials:
References: