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Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

This study has been completed.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati Identifier:
First received: March 20, 2013
Last updated: January 27, 2015
Last verified: March 2013

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.

Condition Intervention
Hemiplegic Cerebral Palsy
Other: FES neuroprosthesis to dorsiflexors on affected leg

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy

Resource links provided by NLM:

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • peak ankle dorsiflexion range during swing phase in gait [ Time Frame: will be assessed at baseline and 3 months after continous use of neuroprosthesis ]

Secondary Outcome Measures:
  • gait efficiency [ Time Frame: after 3 months of neuroprosthesis use ]

Other Outcome Measures:
  • functional skills [ Time Frame: at baseline and 3 months after neuroprosthesis use ]
    will included timed up and downs stairs,six minute walk test, and an obstacle course

Enrollment: 12
Study Start Date: March 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bioness L300


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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)
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Please refer to this study by its identifier: NCT01817179

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Amy F Bailes, PT, MS Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01817179     History of Changes
Other Study ID Numbers: CIN001-Effects of FES/PwP
Study First Received: March 20, 2013
Last Updated: January 27, 2015

Keywords provided by Children's Hospital Medical Center, Cincinnati:
hemiplegia, cerebral palsy, neuroprosthesis, children

Additional relevant MeSH terms:
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases processed this record on May 25, 2017