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Completed

NCT Number: NCT01657994

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined functional electrical stimulation and robotic gait training

Other

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

Other names: Lokomat, RT-50

Primary outcomes

  1. Change in Gross Motor Function Measure-66 using multiple baseline assessments

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

Secondary outcomes

  1. Change in strength via myometry

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  2. Change in Observational Gait Scale

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  3. Change in Modified Ashworth Scale

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  4. Change in Goniometry at the knee

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  5. Change in 6 minute walk

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  6. Change in 10 meter walk

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  7. Change in Children's Assessment of Participation and Enjoyment

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  8. Change in Cerebral Palsy Quality of Life Questionnaire

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

  9. Change in Canadian Occupational Performance Measure

    Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Cerebral Palsy International Research Foundation

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2012
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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