NCT01817179

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 28, 2015

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

March 20, 2013

Last Update Submit

January 27, 2015

Conditions

Hemiplegic Cerebral Palsy

Keywords

hemiplegia, cerebral palsy, neuroprosthesis, children

Outcome Measures

Primary Outcomes (1)

  • peak ankle dorsiflexion range during swing phase in gait

    will be assessed at baseline and 3 months after continous use of neuroprosthesis

Secondary Outcomes (1)

  • gait efficiency

    after 3 months of neuroprosthesis use

Other Outcomes (1)

  • functional skills

    at baseline and 3 months after neuroprosthesis use

Study Arms (1)

FES neuroprosthesis to dorsiflexors on affected side

EXPERIMENTAL

Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.

Other: FES neuroprosthesis to dorsiflexors on affected leg

Interventions

FES neuroprosthesis to dorsiflexors on affected legOTHER
Also known as: Bioness L300
FES neuroprosthesis to dorsiflexors on affected side

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

HemiplegiaCerebral Palsy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Amy F Bailes, PT, MS

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 28, 2015

Record last verified: 2013-03

Locations

US(1)