Clinical trial NCT06622655: Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Official title: Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: exoskeleton device
powered orthosis
cerebral palsy
crouch gait
home use
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: IRCCS Fondazione Stella Maris
name: Fondazione Don Carlo Gnocchi Onlus
name: Fondazione Mondino
First posted: 2024-10-02
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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°

Primary outcomes:
measure: Endurance
timeFrame: Baseline, 3 months and 4 months
measure: Knee extension in mid stance (KEMS)
timeFrame: Baseline, 3 months and 4 months
Secondary outcomes:
measure: Measurements of the Joint range of motions (ROMs) and muscle lengths
timeFrame: Baseline, 3 months and 4 months
measure: Level of spasticity in the lower limbs
timeFrame: Baseline, 3 months and 4 months
measure: Walking speed
timeFrame: Baseline, 3 months and 4 months
measure: Postural and motor abilities
timeFrame: Baseline, 3 months and 4 months
measure: Gait pattern
timeFrame: Baseline, 3 months and 4 months
measure: Self-perception of performance in everyday living
timeFrame: Baseline, 3 months and 4 months
measure: Static balance
timeFrame: Baseline, 3 months and 4 months
measure: Usability and acceptability of the powered orthosis
timeFrame: After the treatment only in the intervention group
measure: Behavioural engagement
timeFrame: After the treatment only in the intervention group
Other outcomes:
measure: Spatiotemporal parameters of gait during daily life
timeFrame: Between baseline and month 3
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
state: Lecco
city: Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Pisa
city: Milano
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
city: Pavia
country: Italy
facility: Fondazione Mondino
city: Roma
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
city: Salerno
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Study officials:
References: