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Trial record 29 of 3489 for:    Louisville

Pediatric Locomotor Training Bladder Study

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ClinicalTrials.gov Identifier: NCT03559036
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
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).

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 : April 30, 2020
Estimated Study Completion Date : April 30, 2020

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
Urine


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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

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 ClinicalTrials.gov identifier (NCT number): NCT03559036


Contacts
Contact: April Herrity, PhD 502-587-4461 aprilherrity@catholichealth.net

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: April Herrity, PhD         
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

Responsible Party: Charles Hubscher, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT03559036     History of Changes
Other Study ID Numbers: 17.1007
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
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
Signs and Symptoms