Pediatric Locomotor Training Bladder Study

NCT ID: NCT03559036

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2026-06-30

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).

Conditions

Spinal Cord Injuries; Neurogenic Bladder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Locomotor Training

Intervention Type: PROCEDURE

Body-weight supported stepping on a treadmill.

Interventions

Locomotor Training

Body-weight supported stepping on a treadmill.

Intervention Type: PROCEDURE

Other Intervention Names

Step Training

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Kosair Charities, Inc.

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Charles Hubscher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Hubscher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

17.1007

Identifier Type: -

Identifier Source: org_study_id