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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Combined functional electrical stimulation and robotic gait training

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: therapy plus fes; robotic gait training plus functional electrical stimulation	Other: Combined functional electrical stimulation and robotic gait training; up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks; Other Names: Lokomat; RT-50

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Gross Motor Function Measure-66 using multiple baseline assessments	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in strength via myometry	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Observational Gait Scale	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Modified Ashworth Scale	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Goniometry at the knee	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 6 minute walk	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 10 meter walk	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Children's Assessment of Participation and Enjoyment	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Cerebral Palsy Quality of Life Questionnaire	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Canadian Occupational Performance Measure	4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Cerebral Palsy International Research Foundation
• Investigators: Principal Investigator: Jilda Vargus-Adams, MD MSc, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (ESTIMATE): August 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: functional electrical stimulation; cerebral palsy; robotic; gait training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: R-796-10