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

Cincinnati Children's Hospital Medical Center logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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