Pediatric Locomotor Training Bladder Study

• ClinicalTrials.gov Identifier: NCT03559036
• Recruitment Status: Active, not recruiting
• First Posted: June 15, 2018
• Last Update Posted: February 14, 2023
• Sponsor: University of Louisville
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust; Kosair Charities, Inc.
• Information provided by (Responsible Party): Charles Hubscher, University of Louisville

Study Description

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).

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Urine

Eligibility Criteria

• 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.

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

Contacts and Locations

Locations

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.

Investigators

• Principal Investigator: Charles Hubscher, PhD; University of Louisville

More Information

• Responsible Party: Charles Hubscher, Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT03559036
• Other Study ID Numbers: 17.1007
• First Posted: June 15, 2018
• Last Update Posted: February 14, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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; Urodynamics

Additional relevant 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