Neuromotor Control During Walking in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: Stochastic Resonance (SR)

• Registration Number: NCT05233748
• Lead Sponsor: University of Delaware

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2022-09
• Primary Completion: 2022-09-28
• Study Completion: 2022-09-28
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stochastic Resonance (SR)	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.

Primary Outcome Measures

Name	Time	Method
Change in Margin of Stability(MOS)	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).

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States