Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Hemiplegic Cerebral Palsy

Treatments: Other: FES neuroprosthesis to dorsiflexors on affected leg

Study type: Interventional

Funder types: Other

Identifiers

NCT01817179

CIN001-Effects of FES/PwP

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

FES neuroprosthesis to dorsiflexors on affected side

Experimental group

Description:

Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.

Treatment:

Other: FES neuroprosthesis to dorsiflexors on affected leg