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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Initial effect: Sagittal knee joint kinematics

Training effect: Sagittal knee joint kinematics

Secondary outcome measures

Initial effect: Sagittal knee kinetics

Initial effect: Step-length of gait

Gait

+3 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bionic PowerUNKNOWN

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,467,011 Total Patients Enrolled

4 Trials studying Cerebral Palsy

91 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaged in this experiment?

"Affirmative. According to the data shared on clinicaltrials.gov, this medical study is presently seeking participants who first posted on May 6th 2022 and last edited June 16th 2022. The researchers are searching for 5 patients from a single site."

Answered by AI

Are there any open slots for participation in this experiment?

"Affirmative, the available information from clinicaltrials.gov affirms that this investigation is presently seeking individuals to take part in it. The trial was first posted on May 6th 2022 and its details were last revised on June 16th of the same year. Five participants are required for this study and recruitment is only occurring at one site."

Answered by AI

Is this clinical experiment accessible to those aged 25 or above?

"This study only includes children aged 5 to 19 years old."

Answered by AI

What aims is this investigation attempting to accomplish?

"The primary evaluation metric for this 6 week trial is the initial effect of sagittal knee joint kinematics. Secondary outcomes include training-induced changes to sagittal knee kinetics, step length, and gait velocity which will be assessed post intervention with Agilik weekly sessions."

Answered by AI

What types of individuals are ideal candidates for this research experiment?

"This clinical trial is selecting 5 minors between the ages of 5 and 19 with spinal cord injuries to participate. Candidates must meet certain criteria such as: knee flexion contracture less than 20 degrees in a supine position, gender-agnostic, able to understand basic commands based on parental report or physician assessment during physical examination, plantar flexion contracture below 10 degrees while neutral foot alignment is achieved, measured foot-thigh angle from -10 to 25 degrees when prone, display crouch gait upon observation by medical personnel (level of deficiency quantified post inclusion via gait analysis), mobility enough for them to walk at least"

Answered by AI

Recent research and studies

Gait & PostureJournal

The Energy Expenditure of Normal and Pathologic Gait

Waters, Robert L., and Sara Mulroy. 1999. “The Energy Expenditure of Normal and Pathologic Gait”. Gait & Posture. Elsevier BV. doi:10.1016/s0966-6362(99)00009-0.

Journal of BiomechanicsJournal

Crouched Postures Reduce the Capacity of Muscles to Extend the Hip and Knee During the Single-limb Stance Phase of Gait

Hicks, Jennifer L., Michael H. Schwartz, Allison S. Arnold, and Scott L. Delp. 2008. “Crouched Postures Reduce the Capacity of Muscles to Extend the Hip and Knee During the Single-limb Stance Phase of Gait”. Journal of Biomechanics. Elsevier BV. doi:10.1016/j.jbiomech.2008.01.002.

Science RoboticsJournal

Robot-driven Downward Pelvic Pull to Improve Crouch Gait in Children with Cerebral Palsy

Kang, J., D. Martelli, V. Vashista, I. Martinez-Hernandez, H. Kim, and S. K. Agrawal. 2017. “Robot-driven Downward Pelvic Pull to Improve Crouch Gait in Children with Cerebral Palsy”. Science Robotics. American Association for the Advancement of Science (AAAS). doi:10.1126/scirobotics.aan2634.

Research in Developmental DisabilitiesJournal