Pediatric Locomotor Training Bladder Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries; Neurogenic Bladder
• Intervention / Treatment: Procedure: Locomotor Training

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 Type: Observational
• Enrollment (Estimated): 6

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Locomotor Training; Body-weight supported stepping on a treadmill.; Other Names: Step Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Storage	Bladder Capacity	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Emptying	Voiding Efficiency	2 years
Bladder Pressure	Leak Point and Maximum Pressure	2 years

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust; Kosair Charities, Inc.
• Investigators: Principal Investigator: Charles Hubscher, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Urodynamics; Locomotor Training
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 17.1007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No