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CompletedNCT01817179Updated Jan 28, 2015

Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

An interventional study of FES neuroprosthesis to dorsiflexors on affected leg in Hemiplegic Cerebral Palsy, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-01-28.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hemiplegic Cerebral Palsy

Keywords

  • hemiplegia, cerebral palsy, neuroprosthesis, children
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 12 is below the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
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

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • OtherFES neuroprosthesis to dorsiflexors on affected leg

    Also known as: Bioness L300

06

What researchers measure

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

    will included timed up and downs stairs,six minute walk test, and an obstacle course

    Time frame: at baseline and 3 months after neuroprosthesis use

07

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01817179
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Mar 22, 2013
Start date
Mar 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 28, 2015

Study contacts

Amy F Bailes, PT, MS
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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