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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657994
• Other study ID #: R-796-10
• Status: Completed
• Phase: N/A
• First received: May 17, 2012
• Last updated: August 31, 2016
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Combined functional electrical stimulation and robotic gait training
up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Cerebral Palsy International Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in strength via myometry		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in Observational Gait Scale		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in Modified Ashworth Scale		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in Goniometry at the knee		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in 6 minute walk		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in 10 meter walk		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in Children's Assessment of Participation and Enjoyment		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in Cerebral Palsy Quality of Life Questionnaire		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No
Secondary	Change in Canadian Occupational Performance Measure		4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment	No