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Brace
Knee-Ankle-Foot Brace for Cerebral Palsy
N/A
Recruiting
Led By Thomas C Bulea, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Less than 10 degrees of plantar flexion contracture in neutral foot alignment
Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the same time
Awards & highlights
Study Summary
This trial is testing a new adjustable brace to improve crouch gait in children with CP.
Who is the study for?
This trial is for children aged 5-17 with movement disorders like CP, muscular dystrophy, spina bifida, or incomplete spinal cord injury who can walk at least 10 feet and follow simple directions. It's also open to healthy volunteers of the same age. Participants should not have other conditions affecting their ability to walk and must not consume caffeine before EEG assessments.Check my eligibility
What is being tested?
The study tests a new knee-ankle-foot brace (EA-KAFO) designed to improve walking in kids with crouch gait due to CP and similar conditions. Over six visits, participants will undergo motion analysis, muscle activity measurements (EMG), brain wave recordings (EEG), knee testing, walking trials, and custom brace fittings.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the adhesive used for taping balls or metal discs during evaluations. Discomfort might occur during electrical stimulation of knees or when adjusting to wearing the new braces.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My foot can almost fully straighten.
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I have trouble fully straightening my knee when I walk.
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I can walk at least 10 feet on my own or with help.
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My knee can almost fully straighten when I lie on my back.
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I am 5 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak knee angle
Secondary outcome measures
measures
Trial Design
1Treatment groups
Experimental Treatment
Group I: There is a single study arm in this feasibility study.Experimental Treatment1 Intervention
All participants will be evaluated using the different configurations of the EA-KAFO (see Table 1 in the protocol), which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton. Each subject will serve as their own control to assess the effect of each configuration of the EA-KAFO interventions.
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Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
880,917 Total Patients Enrolled
Thomas C Bulea, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
1 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk short distances unless I have conditions like cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.I have cerebral palsy and haven't had a seizure in the last year.I am healthy or have a condition affecting my walking due to cerebral palsy, muscular dystrophy, spina bifida, or spinal cord injury.My foot can almost fully straighten.I have trouble fully straightening my knee when I walk.I can walk at least 10 feet on my own or with help.My knee can almost fully straighten when I lie on my back.I am 5 years old or older.I can understand and follow simple instructions.
Research Study Groups:
This trial has the following groups:- Group 1: There is a single study arm in this feasibility study.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an enrollment period for this clinical experiment?
"This clinical trial is actively recruiting patients according to the information provided on clinicaltrials.gov, having been initially posted on July 2nd 2015 and amended most recently on November 11th 2022."
Answered by AI
How many participants will be recruited for this research project?
"Affirmative. According to information on clinicaltrials.gov, the trial which was originally posted on July 2nd 2015 is actively seeking participants. 85 patients need to be recruited from two locations for this investigation."
Answered by AI
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