CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
Agilikdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05330052
NCT05330052N/ACompleted

The Effects of a Powered Knee Orthosis on Gait Kinematics of Children With Knee Extension Deficiency

University of British Columbia·interventional·Posted Apr 15, 2022·Updated May 17, 2024

In Brief

A clinical study evaluating Agilik for Cerebral Palsy and 2 related conditions. Completed, enrolled 4 participants across 1 site.

Detailed Summary

Crouch gait/walking, characterized by an 'over-flexed' knee when the leg is supporting body weight, is common in children with diagnoses of cerebral palsy, spina bifida and other incomplete spinal cord injuries. The "Agilik" is a leg exoskeleton device that aims to improve how children with crouch gait walk. In this study the investigators will quantify the improvement that the Agilik facilitates in children with crouch gait in two ways: 1) the difference the Agilik makes when the participants start using it, and 2) any 'training effects' that can be seen in barefoot walking after six sessions of training with the Agilik.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsBionic Power

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 15, 2022
Enrollment StartMay 6, 2022
Primary CompletionDec 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.2 years ago

Interventions

Agilikdevice

The Agilik is a leg orthosis device supporting the knee joint, and is intended to be worn on one or both the legs. The device is customized for single patient use. It is composed of custom-fabricated polypropylene leg shells (thigh, calf and foot components) with joint supports, actuator, sensors, cabling and a battery waist pack. The Agilik is attached to the patient using straps - two on the thigh and two on the shank. A rotational linkage connects the thigh and calf portions of the device, is placed lateral to the knee joint, and is aligned with the knee center of rotation.