Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT01817179|
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : January 28, 2015
The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.
The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.
|Condition or disease||Intervention/treatment||Phase|
|Hemiplegic Cerebral Palsy||Other: FES neuroprosthesis to dorsiflexors on affected leg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: FES neuroprosthesis to dorsiflexors on affected side
Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.
Other: FES neuroprosthesis to dorsiflexors on affected leg
Other Name: Bioness L300
- peak ankle dorsiflexion range during swing phase in gait [ Time Frame: will be assessed at baseline and 3 months after continous use of neuroprosthesis ]
- gait efficiency [ Time Frame: after 3 months of neuroprosthesis use ]
- functional skills [ Time Frame: at baseline and 3 months after neuroprosthesis use ]will included timed up and downs stairs,six minute walk test, and an obstacle course
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817179
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Amy F Bailes, PT, MS||Children's Hospital Medical Center, Cincinnati|