Status:
COMPLETED
Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Hemiplegic Cerebral Palsy
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perfo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of hemiplegic Cerebral Palsy
- Gross Motor Function Classification System (GMFCS) I or II
- Age 6-17 years inclusive
- Demonstrate foot drop during gait without wearing ankle foot orthosis
- Tolerance to neuroprosthesis stimulation
- Physician referral to participate in intervention
- Passive dorsiflexion to at least neutral with knee extended
- Available to travel to and from study visits
- Ability to follow instructions and cooperate with study protocol
- Caregiver reads and understands English
- Exclusion criteria:
- Any metal implants containing electrical circuitry
- Continuous regular use of neuroprosthesis stimulation previous to study enrollment
- Previous orthopaedic procedure involving tibialis anterior muscle at any time
- Previous orthopaedic procedure to affected limb in the last year
- Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study
- Any condition that PI feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01817179
Start Date
March 1 2013
End Date
December 1 2014
Last Update
January 28 2015
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229