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Neuromotor Control During Walking in Children With Cerebral Palsy

University of Delaware logo

University of Delaware

Status

Completed

Conditions

Cerebral Palsy

Treatments

Device: Stochastic Resonance (SR)

Study type

Interventional

Funder types

Other

Identifiers

NCT05233748
1125634

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

8 to 8 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

34 participants in 2 patient groups

Stochastic Resonance (SR)
Experimental group
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.
Treatment:
Device: Stochastic Resonance (SR)
No Stochastic Resonance (noSR)
No Intervention group
Description:
During this condition, participants will walk on the treadmill while receiving no SR stimulation (noSR) with and without visual perturbations.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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