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New treatment option for Cerebral Palsy (CP)
Official title Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT06622655
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join 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...
- 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...
You likely can't join 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°
See the full eligibility 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...
- 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.
- people 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
- 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°
The study team makes the final eligibility decision.
Where it's taking place
- Bosisio Parini, Lecco, Italy
- Calambrone, Pisa, Italy
- Milan, Italy
- Pavia, Italy
- Roma, Italy
- Salerno, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bosisio Parini, Lecco, Italy; Calambrone, Pisa, Italy; Milan, Italy; Pavia, Italy; Roma, Italy; Salerno, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.