Neuromotor Control During Walking in Children With Cerebral Palsy

NCT05233748 | Completed

• 1 other identifier: 1125634
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

locomotor control; balance

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Stochastic Resonance (SR)

EXPERIMENTAL

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)

No Stochastic Resonance (noSR)

NO INTERVENTION

During this condition, participants will walk on the treadmill while receiving no SR stimulation (noSR) with and without visual perturbations.

Interventions

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.

Stochastic Resonance (SR)

Eligibility Criteria

• Age: 8 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John Jeka, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The SRopt and noSR conditions will be presented in random order generated by a computer program and the subjects will be blinded to either condition, due to SR stimulation being below the sensory threshold i.e subjects do not perceive the stimulation at all.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross sectional study of responses to visual perturbations in two groups, children with CP and age-and sex- matched TD (typical development). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a control / no stochastic resonance (noSR) condition while walking with and without visual perturbations.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: February 10, 2022
• Study Start: October 30, 2020
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

US (1)