NIH Reporter #1ZIACL090103-03

NIH Solicitation for Clinical Trial of Pediatric Robotic Exoskeleton (P.REX/Agilik)

This opportunity from the NIH Clinical Center seeks proposals for a clinical trial evaluating a pediatric robotic exoskeleton for children with movement disorders. - Government Buyer: - National Institutes of Health (NIH) Clinical Center - OEMs and Vendors: - P.REX/Agilik pediatric robotic exoskeleton is specifically mentioned - No other OEMs or vendors are named - Products/Services Requested: - Phase I/II clinical trial services to assess the long-term use of the P.REX/Agilik exoskeleton - Focus on evaluating safety and effectiveness for improving gait in pediatric patients - Outcome measures include gait speed, knee extension, and muscle activation - No specific part numbers or purchase quantities provided - Unique or Notable Requirements: - Emphasis on clinical trial design, recruitment targets, and interim analysis - The opportunity is centered on a specific device (P.REX/Agilik) for a targeted pediatric population

Description

This NIH grant opportunity supports a phase I/II clinical trial to evaluate the long-term use of a pediatric robotic exoskeleton (P.REX/Agilik) aimed at improving gait in children with movement disorders. The study assesses safety and effectiveness through multiple outcome measures including gait speed, knee extension, and muscle activation. Recruitment began in May 2023 with a target of 13 participants per group and a total accrual of 14 participants to date. An interim analysis is planned after reaching 50% enrollment.

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