Neuromotor Control During Walking in Children With Cerebral Palsy

• Sponsor: University of Delaware (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05233748
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Device: Stochastic Resonance (SR)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Participant)
• Masking Description: 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.
• Primary Purpose: Basic Science
• Official Title: Neuromotor Control During Walking in Children With Cerebral Palsy
• Actual Study Start Date: Oct 30, 2020
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Delaware	Newark	Delaware	United States	19713

Sponsors and Collaborators

• University of Delaware

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Delaware
• ClinicalTrials.gov Identifier: NCT05233748
• Other Study ID Numbers: 1125634
• First Posted: Feb 10, 2022
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Delaware: locomotor control; balance
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

No Results Posted as of Jun 1, 2022