Pediatric Locomotor Training Bladder Study

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Spinal Cord Injuries, Neurogenic Bladder

Intervention / Treatment
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* Procedure: Locomotor Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Locomotor Training<br>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<br>* Body-weight supported stepping on a treadmill.<br>* Other names: Step Training;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locomotor Training, Urodynamics