Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817179
• Other study ID #: CIN001-Effects of FES/PwP
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: January 27, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Other:
• FES neuroprosthesis to dorsiflexors on affected leg

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	peak ankle dorsiflexion range during swing phase in gait		will be assessed at baseline and 3 months after continous use of neuroprosthesis	No
Secondary	gait efficiency		after 3 months of neuroprosthesis use	No