Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
Completed · Not applicable
Conditions studied: Hemiplegic Cerebral Palsy
In brief
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 perform other functional activities. 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.
Key facts
- Study ID
- NCT01817179
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 12
- Starts
- 2013-03-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-01-28
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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