Clinical trial NCT03559036: Pediatric Locomotor Training Bladder Study
Official title: Impact of Activity-Dependent Plasticity on Bladder Function After Pediatric Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries
Neurogenic Bladder
Keywords: Locomotor Training
Urodynamics
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: Kosair Charities, Inc.
First posted: 2018-06-15
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Bladder Storage
timeFrame: 2 years
Secondary outcomes:
measure: Bladder Emptying
timeFrame: 2 years
measure: Bladder Pressure
timeFrame: 2 years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Charles Hubscher, PhD
role: PRINCIPAL_INVESTIGATOR
References: