Neuromotor Control During Walking in Children With Cerebral Palsy

NCT ID: NCT05233748

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2022-09-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stochastic Resonance (SR)

Intervention Type: 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.

No Stochastic Resonance (noSR)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Jeka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

1125634

Identifier Type: -

Identifier Source: org_study_id