Hemiplegic Cerebral Palsy
Conditions
Keywords
hemiplegia, cerebral palsy, neuroprosthesis, children
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 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.
Interventions
OTHERFES neuroprosthesis to dorsiflexors on affected leg
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak ankle dorsiflexion range during swing phase in gait | will be assessed at baseline and 3 months after continous use of neuroprosthesis |
Secondary
| Measure | Time frame |
|---|---|
| gait efficiency | after 3 months of neuroprosthesis use |
Other
| Measure | Time frame | Description |
|---|---|---|
| functional skills | at baseline and 3 months after neuroprosthesis use | will included timed up and downs stairs,six minute walk test, and an obstacle course |
Countries
United States
Outcome results
None listed