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NCT04077346

Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury

Enrolling by Invitation
NAAges 4–12InterventionalTreatment
University of Louisville
~8 participants
Updated 2025-02-26 on ClinicalTrials.gov
What's tested:Biostim-5 transcutaneous spinal stimulatorTranscutaneous Spinal Stimulator + Activity Based Locomotor Training

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Movement observation (live observation) with video review of the ability to initiate and take an independent, voluntary step from a position of standing.
Measured over Change in ability to voluntarily step comparing pre-stimulation to during and post stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60, within a 4 month period
+2 more outcomes measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Andrea L Behrman, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children with acquired, upper motor neuron (T10 and above) SCI, traumatic and non-traumatic,
Chronic injury, defined as greater than one year post injury
Age 4-12 years,
Discharged from inpatient rehabilitation,
Unable to stand, walk, or initiate steps.

Exclusion

Botox use within past 3 months
Current oral baclofen use,
Baclofen pump in use,
Musculoskeletal impairment limiting range of motion, unhealed fracture or other medical complication limiting participation,
Prior surgery for scoliosis, post SCI
Congenital SCI,
Total ventilator dependence.
Unwilling or unable to wean from baclofen during training,
Use of braces (trunk or lower limb brace).

What this trial measures

  • Movement observation (live observation) with video review of the ability to initiate and take an independent, voluntary step from a position of standing.Change in ability to voluntarily step comparing pre-stimulation to during and post stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60, within a 4 month period

    Ability to take step independently with minimal or no external support. Participant can use a walker or other assistive device for balance and support. The participant will stand independently and lift a limb/foot off the ground and step forward making the same foot contact the ground in front as when taking a first step. This will be measured via movement observation by a licensed physical therapist and videotaped. A single step is all that is required. If more than one step is observed, this information will be documented and also videotaped. No manual assistance will be provided during the assessment for a voluntary step. The achievement of an independent step, foot leaves the ground and is placed forward, is the only criteria for the 'step'.

  • Electromyography (EMG) recording of lower extremity and trunk musclesChange in EMG: pre-stimulation compared to during stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60 within a 4 month period

    Measurement of muscle and nerve functions. The muscle activities are reported in microvolts.

  • Angular excursions of lower extremityChange in limb angle excursions: Pre-stimulation compared to during-stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60 within a 4 month period

    Degrees of flexion/extension, adduction/abduction, and rotation, using wireless motion sensors.