Clinical Trials Directory

Trials / Completed

CompletedNCT03226860

Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
MultiCare Health System Research Institute · Academic / Other
Sex
All
Age
5 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This research study will see if electrical stimulation increases heel strike (heel hits the floor first when walking), decreases limp, helps muscle contraction, and improves balance in children with a hemiplegic leg. An experimental electrical stimulation device called the Gait MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.

Detailed description

Physical therapists focus on improving gait and balance in children with hemiplegic cerebral palsy (HCP). Functional electrical stimulation (FES) has the potential to improve strength and functional gait for children with HCP. The investigators hypothesize that a new FES system stimulating the dorsiflexor (DF) and plantarflexor (PF) muscles alternately at the correct time during gait, would lead to a significant improvement (p\<.05) in foot contact, gait symmetry and balance, compared to 12 weeks of a healthy lifestyle program called 5210.

Conditions

Interventions

TypeNameDescription
DEVICEGait Myoelectric StimulatorElectrical stimulation during gait for children with CP
OTHER5210Children will eat 5 fruits/vegetables each day, watch 2 hours or less of screen time, perform 1 hour or more of physical activity, and drink 0 sugar-sweetened beverages.

Timeline

Start date
2015-08-03
Primary completion
2016-08-15
Completion
2016-12-01
First posted
2017-07-24
Last updated
2017-07-24

Source: ClinicalTrials.gov record NCT03226860. Inclusion in this directory is not an endorsement.