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Neuromotor Control During Walking in Children With Cerebral Palsy

Neuromotor Control During Walking in Children With Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05233748
Enrollment
34
Registered
2022-02-10
Start date
2020-10-30
Completion date
2022-09-28
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

locomotor control, balance

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.

Interventions

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.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 8 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026