Impact of Activity-Dependent Plasticity on Bladder Function After Pediatric Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Louisville
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Bladder Storage
Study Overview
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.
Detailed 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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Bladder Storage
Time Frame: 2 years
Bladder Capacity
Secondary Outcomes
- Bladder Emptying(2 years)
- Bladder Pressure(2 years)
Investigators
Charles Hubscher
Professor
University of Louisville