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

NCT05330052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-05-17

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Spina Bifida
  • Spinal Cord Injuries

Interventions

DEVICE

Agilik

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.

Sponsors & Collaborators

  • Bionic Power

    collaborator UNKNOWN
  • University of British Columbia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2023-12-23
Completion
2023-12-23

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05330052 on ClinicalTrials.gov