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Brace

Knee-Ankle-Foot Brace for Cerebral Palsy

N/A

Recruiting

Led By Thomas C Bulea, Ph.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)

Must not have

Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time

Additional exclusion criteria for individuals with cerebral palsy: A history of a seizure in the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the same time

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can walk short distances unless I have conditions like cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.

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I have cerebral palsy and haven't had a seizure in the last year.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak knee angle

Secondary study objectives

measures

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: 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.

0 / 7Eligibility criteria met