Neuromotor Control During Walking in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Neuromotor Control During Walking in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05233748
• Other study ID #: 1125634
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: September 28, 2022

Study information

• Verified date: September 2022
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One out of every three children with cerebral palsy (CP) falls daily, with more than half of the falls occurring while walking. To avoid falling, the nervous system must continuously monitor how the body moves and, when an imbalance is detected, activate muscles for an appropriate correction. In this project, we will use small electrical stimulation of muscles and tendons that enhances the sense of body positioning, to allow children with CP to generate more accurate balance corrections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 8 Years

Eligibility

Inclusion Criteria:

• Age 8 - 24 years
• Diagnosis of spastic diplegic or hemiplegic CP (for participants with CP group only)
• GMFCS classification level I or II (ability to walk independently with using any assistive device)
• Visual, perceptual, and cognitive/ communication skills to follow multiple step commands
• Seizure-free or well controlled seizures
• Ability to communicate pain or discomfort during testing procedures
• Parental/guardian consent and child assent/consent

Exclusion Criteria:

• Diagnosis of athetoid, ataxic or quadriplegic CP
• Significant scoliosis (scoliometer angle > 9°)
• History of selective dorsal root rhizotomy
• Botox injections in the lower limb within the past 6 months
• Severe spasticity of the lower extremity muscles (e.g. a score of 4 on the Modified Ashworth Scale)
• Severely limited range of motion/ irreversible muscle contractures
• Lower extremity surgery or fractures in the year prior testing
• Joint instability or dislocation in the lower extremities
• Marked visual or hearing deficits

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Stochastic Resonance (SR)
The system consists of six linear isolated stimulators (STMISOLA, Biopac Systems, Inc., Goleta, USA). The SR signal (Gaussian White Noise, zero mean) will be generated through a 16 bit PCI 6733 National Instruments multifunction data acquisition card by a custom LabView program. The stimulation sites include the ankle, lateral soleus, peroneus longus, and tibialis anterior muscles and the hip.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Margin of Stability(MOS)	MOS refers to the distance between extrapolated center of mass (which includes center of mass position and velocity) and the base of support. It has been previously used to measure balance in children with cerebral palsy, patients with stroke, Parkinson Disease, and Multiple Sclerosis. We will measure center of mass using kinetics and kinematic computed through a motion capture system(Qualysis).; For the visual perturbation conditions, we will use center of mass excursion as the primary outcome measure (since it has been used in prior studies in children and adults using visual perturbation protocols).	At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation MOS.