Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy

NCT ID: NCT01657994

Last Updated: 2016-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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therapy plus fes

robotic gait training plus functional electrical stimulation

Group Type EXPERIMENTAL

Combined functional electrical stimulation and robotic gait training

Intervention Type OTHER

up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks

Interventions

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Combined functional electrical stimulation and robotic gait training

up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks

Intervention Type OTHER

Other Intervention Names

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Lokomat RT-50

Eligibility Criteria

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Inclusion Criteria

* GMFCS II, III, or IV cerebral palsy
* 5-12 years of age
* meet safety criteria for robotic gait training (\<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)
* meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)

Exclusion Criteria

* planned major intervention during study period
* contractures that interfere with upright stance
* history of non-traumatic long bone fracture or clinically significant osteoporosis
* significant concurrent illness
* significant condition not typically associated with cerebral palsy
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cerebral Palsy International Research Foundation

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jilda Vargus-Adams, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R-796-10

Identifier Type: -

Identifier Source: org_study_id

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