Pediatric Locomotor Training Bladder Study

Active, not recruiting

• Conditions: Spinal Cord Injuries; Neurogenic Bladder
• Interventions: Procedure: Locomotor Training

• Registration Number: NCT03559036
• Lead Sponsor: University of Louisville

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 Timeline

• Study Start: 2018-04-26
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Locomotor Training	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.

Primary Outcome Measures

Name	Time	Method
Bladder Storage	2 years	Bladder Capacity

Secondary Outcome Measures

Name	Time	Method
Bladder Emptying	2 years	Voiding Efficiency
Bladder Pressure	2 years	Leak Point and Maximum Pressure

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States