Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622655
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Clinical Improvement Due to the Home Use of Agilik in Children with Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Agilikhome Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children with Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Agilikhome
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None