Clinical trial NCT01657994: Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
Official title: Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
gait training
robotic
functional electrical stimulation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Cerebral Palsy International Research Foundation
First posted: 2012-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Gross Motor Function Measure-66 using multiple baseline assessments
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Secondary outcomes:
measure: Change in strength via myometry
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in Observational Gait Scale
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in Modified Ashworth Scale
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in Goniometry at the knee
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in 6 minute walk
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in 10 meter walk
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in Children's Assessment of Participation and Enjoyment
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in Cerebral Palsy Quality of Life Questionnaire
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
measure: Change in Canadian Occupational Performance Measure
timeFrame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jilda Vargus-Adams, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: