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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES neuroprosthesis to dorsiflexors on affected side | Experimental | Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES neuroprosthesis to dorsiflexors on affected leg | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| peak ankle dorsiflexion range during swing phase in gait | will be assessed at baseline and 3 months after continous use of neuroprosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| gait efficiency | after 3 months of neuroprosthesis use |
| Measure | Description | Time Frame |
|---|---|---|
| functional skills | will included timed up and downs stairs,six minute walk test, and an obstacle course | at baseline and 3 months after neuroprosthesis use |
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
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)
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| Name | Affiliation | Role |
|---|---|---|
| Amy F Bailes, PT, MS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |