Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
NCT ID: NCT01817179
Last Updated: 2015-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2013-03-31
2014-12-31
Brief Summary
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The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FES neuroprosthesis to dorsiflexors on affected side
Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.
FES neuroprosthesis to dorsiflexors on affected leg
Interventions
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FES neuroprosthesis to dorsiflexors on affected leg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
6 Years
17 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Amy F Bailes, PT, MS
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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CIN001-Effects of FES/PwP
Identifier Type: -
Identifier Source: org_study_id
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