Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: FES neuroprosthesis to dorsiflexors on affected leg

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES neuroprosthesis to dorsiflexors on affected side; Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.	Other: FES neuroprosthesis to dorsiflexors on affected leg; Other Names: Bioness L300

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
gait efficiency	after 3 months of neuroprosthesis use

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Amy F Bailes, PT, MS, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: hemiplegia, cerebral palsy, neuroprosthesis, children
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: CIN001-Effects of FES/PwP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No