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ENROLLING BY INVITATION
NCT06808035
NA

Understanding Perinatal Spinal Cord Injury

Sponsor: University of Louisville

View on ClinicalTrials.gov

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.

Official title: Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions

Key Details

Gender

All

Age Range

3 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-01-09

Completion Date

2027-01

Last Updated

2025-02-05

Healthy Volunteers

No

Interventions

OTHER

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.

DEVICE

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.

Locations (1)

University of Louisville

Louisville, Kentucky, United States