Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-06 @ 3:02 AM
Study NCT ID:
NCT03226860
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Sponsor:
MultiCare Health System Research Institute
Organization:
Study Overview
Official Title:
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: