Neuromotor Control During Walking in Children With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Stochastic Resonance (SR)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stochastic Resonance (SR); During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations.	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.
No Intervention: No Stochastic Resonance (noSR); During this condition, participants will walk on the treadmill while receiving no SR stimulation (noSR) with and without visual perturbations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: John Jeka, PhD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: balance; locomotor control
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 1125634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No