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Completed

NCT Number: NCT01817179

Functional Electrical Stimulation for 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.

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Key information

Conditions

Hemiplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FES neuroprosthesis to dorsiflexors on affected leg

Other

Other names: Bioness L300

Primary outcomes

  1. 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 outcomes

  1. gait efficiency

    Time frame: after 3 months of neuroprosthesis use

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2013
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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