Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01817179
First received: March 20, 2013
Last updated: January 8, 2014
Last verified: March 2013
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gait efficiency [ Time Frame: after 3 months of neuroprosthesis use ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • functional skills [ Time Frame: at baseline and 3 months after neuroprosthesis use ] [ Designated as safety issue: No ]
    will included timed up and downs stairs,six minute walk test, and an obstacle course


Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817179

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

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01817179     History of Changes
Other Study ID Numbers: CIN001-Effects of FES/PwP
Study First Received: March 20, 2013
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014