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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stochastic Resonance (SR)

Device

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.

Primary outcomes

Change in Margin of Stability(MOS)

Time frame: At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation 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).

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Feb 10, 2022
Registry last updated: Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed