Pediatric Locomotor Training Bladder Study

NCT03559036 | Active Not Recruiting DMC

• 1 other identifier: 17.1007
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder dysfunction is one of the most important factors influencing duration and quality of life in children with spinal cord injury. Effective bladder control comprises a major aspect of a child's life with SCI and is especially challenging due to the rapid changes in a child's physical and cognitive development. Urological consequences secondary to a neurogenic bladder are responsible for many clinical complications post-spinal cord injury, including repeated urinary tract infections, autonomic dysreflexia, lifelong urologic care, and many hospitalizations. Alternative approaches to bladder management that focus on recovery of function and age-appropriate independence are needed. Prior research findings in our lab in adult participants indicate a benefit of locomotor training on bladder function. The purpose of this study is to determine with quantitative unbiased urodynamic outcome measures if locomotor training, provided to children with spinal cord injury, impacts the developing urinary system.

Conditions

Spinal Cord Injuries; Neurogenic Bladder

Keywords

Locomotor Training; Urodynamics

Outcome Measures

Primary Outcomes (1)

• Bladder Storage

  Bladder Capacity

  2 years

Secondary Outcomes (2)

• Bladder Emptying

  2 years

• Bladder Pressure

  2 years

Study Arms (1)

Locomotor Training

Assessments for bladder function will be conducted pre-training and following 80 sessions of locomotor training. Locomotor training consists of body-weight supported stepping on a treadmill for one hour.

Procedure: Locomotor Training

Interventions

Locomotor Training PROCEDURE

Body-weight supported stepping on a treadmill.

Also known as: Step Training

Locomotor Training

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, 2 to 18 years old, who sustained an upper motor neuron spinal cord injury and are medically approved for enrollment in an outpatient, standardized locomotor training program at the University of Louisville (either clinic or research-based) are eligible for participation. Each participant will serve as his/her own control reducing the variability among individuals related to the injury itself, time since injury, medications taken, therapies received, differences in degree of bladder dysfunction, capacity to independently void prior to injury, and many other factors that cannot be controlled in the human experience.

You may qualify if:

• Supra-sacral, non-progressive spinal cord injury
• Bladder dysfunction post-injury

You may not qualify if:

• Use of anti-spasticity medications or unwillingness to wean off of medications
• Botox (onabotulinumtoxinA) in the bladder within 9 months of the study
• Bladder dysfunction or urinary tract impairment prior to injury

Sponsors & Collaborators

• University of Louisville: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Kosair Charities, Inc.: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Hubscher, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: April 26, 2018
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)