EA-KAFO for Cerebral Palsy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cerebral Palsy+7 More
EA-KAFO - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new adjustable brace to improve crouch gait in children with CP.

Eligible Conditions
  • Cerebral Palsy
  • Spinal Cord
  • Muscular Dystrophy, Duchenne
  • Spina Bifida

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cerebral Palsy

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: At the same time

At the same time
measures
This outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.
Peak knee angle

Trial Safety

Safety Progress

1 of 3

Other trials for Cerebral Palsy

Trial Design

3 Treatment Groups

There is a single study arm in this feasibility study.
1 of 3
Feasibility Arm
1 of 3
There is a single study arm in this feasibility study
1 of 3
Experimental Treatment

85 Total Participants · 3 Treatment Groups

Primary Treatment: EA-KAFO · No Placebo Group · N/A

There is a single study arm in this feasibility study.
Device
Experimental Group · 1 Intervention: EA-KAFO · Intervention Types: Device
Feasibility Arm
Device
Experimental Group · 1 Intervention: EA-KAFO · Intervention Types: Device
There is a single study arm in this feasibility study
Device
Experimental Group · 1 Intervention: EA-KAFO · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the same time

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
375 Previous Clinical Trials
985,739 Total Patients Enrolled
6 Trials studying Cerebral Palsy
821 Patients Enrolled for Cerebral Palsy
Thomas C Bulea, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have less than 10 degrees of plantar flexion contracture in neutral foot alignment.
The measured foot-thigh angle of -10 to 25 degrees in prone position.
You are able to provide verbal/written consent.\n
You are able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
You have less than 5 degrees of knee flexion contracture with hip extended in supine position
You are able to walk at least 10 feet without stopping with or without a walking aid.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.