Recruiting

ABRT & scTS

Sponsor:

University of Louisville

Code:

NCT06808035

Conditions

Perinatal Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Not accepted

Interventions

Activity-Based Recovery Training

Transcutaneous Spinal Cord Stimulation

Study Details

Brief summary:

The purpose of this study is to deepen our understanding of children who have a cervical spinal cord injury obtained in utero or at birth and examine the effects of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS). This is a within subjects, pre-post design study. Neurophysiological, sensorimotor, and autonomic assessments will occur pre, interim, and post 40 sessions of ABRT in conjunction with scTs.

Conditions

Perinatal Spinal Cord Injury

Study ID

NCT06808035

Start date

Jan 9, 2024

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosed with a perinatal (injured in utero or at birth), upper motor neuron spinal cord injury involving cervical spinal levels
  • discharged from inpatient hospitalization/inpatient rehabilitation

Exclusion Criteria:

  • Botox use within the past 3 months
  • Current oral baclofen or baclofen pump use
  • Musculoskeletal impairment limiting range of motion (e.g. severe scoliosis), unhealed fracture, or other medical impairment limiting study participation
  • History of allodynia (heightened skin sensitivity typically at the level of the lesion site)
  • History of scoliosis surgery
  • Ventilator-dependence
  • Unwillingness to wean from daytime use of thoroco/lumbosacral orthosis and ankle/foot orthosis during the intervention period

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cervical Perinatal SCI

Participants with high cervical and low cervical SCI will perform tailored ABRT+scTS. Pre, interim, and post assessments of neurophysiological, sensorimotor, and autonomic function will be compared within-subjects and between high and low cervical SCI groups. Participants will come for daily activity-based recovery training (ABRT) + transcutaneous spinal stimulation (scTS). ABRT+scTS will take place 5 days per week for approximately 2.5 hours each (1.5 hours of lower extremity training and 1 hour of upper extremity training) for a total of 40 sessions consisting of facilitated sitting, standing, stepping, and UE motor tasks such as grasping, reaching, and hand manipulations.

Interventions

Activity-Based Recovery Training

ABRT uses task-specific training to improve neuromuscular capacity. ABRT will be tailored to participant presentation. Activity-Based Locomotor Training consists of stepping, standing, and sitting activities on a body weight support (BWS) treadmill using a harness and while overground. Therapists and trainers provide hands-on assistance for safety and kinematics. BWS is varied during sessions with a goal of optimal kinematics at the lowest BWS. Activities performed standing will focus on alignment incorporating static, active, and dynamic tasks. Activities performed during overground are based on neuromuscular capacity and appropriate developmental and functional levels. Principles of ABRT will be shared with parents/caregivers to foster activity in the home and community. Activity-Based Upper Extremity Training uses task-specific training of the trunk and upper extremities administered in sitting or standing via manual facilitation or support in a stander for best posture.

Transcutaneous Spinal Cord Stimulation

Transcutaneous Spinal Cord Stimulation (scTs) is a non-invasive stimulation administered over the skin using a modulated biphasic or monophasic waveform at 15-90Hz and a carrier frequency of 5-10kHz. Bouts of scTs at the cervical, thoracic, lumbar, and/or coccygeal level will be administered midline or just lateral to the spinous processes during activity-based recovery training.

Primary outcome measure

  • Participant Specific Outcome Measures [ Time Frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months) ]

Central Contacts and Locations

Central contacts

Lisa R. Clayton, CCRP

502-569-7996kidskickparalysis@louisville.edu

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Lisa R. Clayton, CCRP

502-569-7996kidskickparalysis@louisville.edu

Principal Investigator:

Andrea L. Behrman, PhD, PT

More Information

Sponsor

University of Louisville

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Spinal Cord Injury
  • Activity-Based Recovery Training
  • Perinatal-Onset
  • Transcutaneous Spinal Cord Stimulation
  • Whole-Systems
  • Pediatric Spinal Cord Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-09-11.