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

NCT01657994 | Completed

• 1 other identifier: R-796-10
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; gait training; robotic; functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

therapy plus fes

EXPERIMENTAL

robotic gait training plus functional electrical stimulation

Other: Combined functional electrical stimulation and robotic gait training

Interventions

Combined functional electrical stimulation and robotic gait training OTHER

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

Also known as: Lokomat, RT-50

therapy plus fes

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• GMFCS II, III, or IV cerebral palsy
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Cerebral Palsy International Research Foundation: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jilda Vargus-Adams, MD MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: August 6, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

US (1)