Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Pediatric Locomotor Training Bladder Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03559036
Recruitment Status : Active, not recruiting
First Posted : June 15, 2018
Last Update Posted : February 14, 2023
The Leona M. and Harry B. Helmsley Charitable Trust
Kosair Charities, Inc.
Information provided by (Responsible Party):
Charles Hubscher, 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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Neurogenic Bladder 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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Activity-Dependent Plasticity on Bladder Function After Pediatric Spinal Cord Injury
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

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 Name: Step Training

Primary Outcome Measures :
  1. Bladder Storage [ Time Frame: 2 years ]
    Bladder Capacity

Secondary Outcome Measures :
  1. Bladder Emptying [ Time Frame: 2 years ]
    Voiding Efficiency

  2. Bladder Pressure [ Time Frame: 2 years ]
    Leak Point and Maximum Pressure

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03559036

Layout table for location information
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
The Leona M. and Harry B. Helmsley Charitable Trust
Kosair Charities, Inc.
Layout table for investigator information
Principal Investigator: Charles Hubscher, PhD University of Louisville
Layout table for additonal information
Responsible Party: Charles Hubscher, Professor, University of Louisville Identifier: NCT03559036    
Other Study ID Numbers: 17.1007
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charles Hubscher, University of Louisville:
Locomotor Training
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases