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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Combined functional electrical stimulation and robotic gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT01657994

R-796-10

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

therapy plus fes

Experimental group

Description:

robotic gait training plus functional electrical stimulation

Treatment:

Other: Combined functional electrical stimulation and robotic gait training