Pediatric Locomotor Training Bladder Study

Spinal Cord Injuries Clinical Trial

Official title:

Impact of Activity-Dependent Plasticity on Bladder Function After Pediatric Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03559036
• Other study ID #: 17.1007
• Status: Active, not recruiting
• Start date: April 26, 2018
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Our overall hypothesis is that spinal cord injury-induced bladder dysfunction, facilitated by the loss of supra-spinal connections and subsequent alterations of the lumbosacral circuitry, can be ameliorated through activity-based therapy that regulates the state of detrusor-sphincter dyssynergia and normalizes release of neurotrophic factors known to contribute to bladder hyper-reflexia. The primary study aim is to determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after incomplete and complete spinal cord injury in children on bladder storage, voiding, biomarkers, and quality of life (parent-reported during baseline and exit interview). A secondary aim is to develop a scale for classifying bladder recovery after spinal cord injury based either on the pattern of storage and voiding prior to injury (if the child had bladder control prior to injury) or on established patterns of micturition development (if the child was injured prior to experiencing bladder control).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

Intervention

Procedure:
• Locomotor Training
Body-weight supported stepping on a treadmill.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Louisville	Kosair Charities, Inc., The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Storage	Bladder Capacity	2 years
Secondary	Bladder Emptying	Voiding Efficiency	2 years
Secondary	Bladder Pressure	Leak Point and Maximum Pressure	2 years