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NCT05091463

Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI

UNKNOWN
NAAges 3–12InterventionalTreatment
University of Louisville
~12 participants
Updated 2024-06-24 on ClinicalTrials.gov
What's tested:Biostim-5/Neostim transcutaneous spinal stimulator

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Segmental Assessment of Trunk Control
Measured over Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
+1 more outcome 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

Chronic (\> 1 year since injury), Acquired Upper motor Neuron injury (T10 and above)
Discharged from in-patient rehabilitation
Moderate to severe trunk control deficit as assessed by the Segmental Assessment of Trunk Control (SATCo, score \<16/20) OR unable to fully sit upright while lifting their arms or reaching outside of their base of support while maintaining posture
Novice to activity-based locomotor training and transcutaneous spinal stimulation

Exclusion

Botox use within the past 3 months
Current oral baclofen use and unwillingness or unable to wean under medical guidance
Baclofen pump use
Musculoskeletal impairment limiting range of motion, unhealed fracture, or other medical complication limiting participation
Prior surgery for scoliosis
Unwillingness to wean from the use of thoraco-lumbosacral orthosis (TLSO) during study
Spina Bifida as etiology of spinal cord injury

What this trial measures

  • Segmental Assessment of Trunk ControlChange from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)

    Participants will be tested in a seated position with arms and back unsupported on a bench with hip and knee both at 90 degrees of flexion and feet supported. Trunk control will be examined with a therapist progressively changing the level of support, starting at the shoulder girdle and axilla to assess cervical (head) control. They will then progress to the inferior-scapula (mid-thoracic), lower-ribs (lower thoracic), below-ribs (upper lumbar), pelvis (lower lumbar) and no support, to measure full trunk control. Pelvis will be placed in a neutral position via manual support for all testing, except for the no support level.

  • Modified Function Reach (MFR)Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)

    Participants will be in a sitting position with hip, knees, and ankles in 90 degrees flexion, with feet flat on the floor. The initial reach will be measured using a yard stick with participant reaching (leaning) as far as possible (front, right, and left). Distance covered, in centimeters from initial position to furthest reaching at the level of the 3rd metacarpal, will be recorded in all 3 directions.