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Neuromotor Control During Walking in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stochastic Resonance (SR)

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring locomotor control, balance

Eligibility Criteria

8 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stochastic Resonance (SR)

No Stochastic Resonance (noSR)

Arm Description

During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05233748

First Posted

October 14, 2021

Last Updated

September 28, 2022

Sponsor

University of Delaware

1. Study Identification

Unique Protocol Identification Number

NCT05233748

Brief Title

Neuromotor Control During Walking in Children With Cerebral Palsy

Official Title

Neuromotor Control During Walking in Children With Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 30, 2020 (Actual)

Primary Completion Date

September 28, 2022 (Actual)

Study Completion Date

September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

locomotor control, balance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

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.

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stochastic Resonance (SR)

Arm Type

Experimental

Arm Description

During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations.

Arm Title

No Stochastic Resonance (noSR)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Stochastic Resonance (SR)

Intervention Description

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 Outcome Measure Information:

Title

Change in Margin of Stability(MOS)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Jeka, PhD

Organizational Affiliation

University of Delaware

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Delaware

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Neuromotor Control During Walking in Children With Cerebral Palsy

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