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Pediatric Locomotor Training Bladder Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03559036
Enrollment
6
Registered
2018-06-15
Start date
2018-04-26
Completion date
2026-06-30
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries, Neurogenic Bladder

Keywords

Locomotor Training, Urodynamics

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).

Interventions

Body-weight supported stepping on a treadmill.

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Bladder Storage2 yearsBladder Capacity

Secondary

MeasureTime frameDescription
Bladder Emptying2 yearsVoiding Efficiency
Bladder Pressure2 yearsLeak Point and Maximum Pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026