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Leg Exoskeleton Device

Powered Knee Orthosis for Cerebral Palsy

N/A
Waitlist Available
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 20 degrees of knee flexion contracture with hip extended in supine position.
Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of the Agilik, a leg exoskeleton device, on children with crouch gait. Crouch gait is characterized by an 'over-flexed' knee when the leg is supporting body weight, and is common in children with diagnoses of cerebral palsy, spina bifida and other incomplete spinal cord injuries. 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

Who is the study for?
This trial is for children aged 5-19 with cerebral palsy, spina bifida, or spinal cord injuries who walk with a crouch gait. They must be able to walk at least 10 feet and follow simple directions. Those with severe joint stiffness or contractures may not qualify.
What is being tested?
The 'Agilik' powered knee orthosis is being tested to see if it can improve walking patterns in children with knee extension deficiency. The study will measure immediate changes when using the device and any lasting effects after six training sessions.
What are the potential side effects?
While specific side effects are not listed, devices like the Agilik could potentially cause skin irritation, discomfort while wearing, muscle fatigue from use, or impact balance during initial use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My knee can almost fully straighten when I lie on my back.
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My foot can almost fully straighten.
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I am between 5 and 19 years old.
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I can walk at least 10 feet on my own or with help from a walking aid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Initial effect: Sagittal knee joint kinematics
Training effect: Sagittal knee joint kinematics
Secondary study objectives
Initial effect: Sagittal knee kinetics
Initial effect: Step-length of gait
Gait
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AgilikExperimental Treatment1 Intervention
The participant will be provided custom knee orthoses (the Agilik) to trial in this study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Agilik
2022
N/A
~10

Find a Location

Who is running the clinical trial?

Bionic PowerUNKNOWN
University of British ColumbiaLead Sponsor
1,472 Previous Clinical Trials
2,489,586 Total Patients Enrolled
5 Trials studying Cerebral Palsy
2,091 Patients Enrolled for Cerebral Palsy
~1 spots leftby Dec 2025
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