Spinal Cord InjuriesNCT03559036
Pediatric Locomotor Training Bladder Study
An observational study of Spinal Cord Injuries and Neurogenic Bladder, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder
- What is being tested?
- Locomotor Training
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2018to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Supra-sacral, non-progressive spinal cord injury
- Bladder dysfunction post-injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Impact of Activity-Dependent Plasticity on Bladder Function After Pediatric Spinal Cord Injury
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.
Read the 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
- Being tested
- Locomotor Training
- Keywords
- Locomotor Training, Urodynamics
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotor TrainingProcedure or surgery
Also called Step Training
Body-weight supported stepping on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Storage
Bladder Capacity
Measured: 2 years
Secondary outcomes (2)
Bladder Emptying
Voiding Efficiency
Measured: 2 years
Bladder Pressure
Leak Point and Maximum Pressure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start26 Apr 2018
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Kosair Charities, Inc.
- Responsible party
- Principal investigator, Charles Hubscher, University of Louisville
- Investigators
- Charles Hubscher, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559036
- Sponsor's protocol ID
- 17.1007
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2018
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Activity-Dependent Plasticity on Bladder Function After Pediatric Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03559036
- Acronym / sponsor ID
- 17.1007
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder
- Keywords
- Locomotor Training, Urodynamics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Kosair Charities, Inc.
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locomotor Training | – | Procedure: Locomotor TrainingAssessments 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Supra-sacral, non-progressive spinal cord injury
- Bladder dysfunction post-injury
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locomotor TrainingAlso: Step TrainingBody-weight supported stepping on a treadmill. | Procedure or surgery | Locomotor Training |
Primary outcome
Bladder Storage
Time frame: 2 years
Bladder Capacity
2 secondary outcomes
Bladder Emptying
Time frame: 2 years
Bladder Pressure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hubscher, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Neurogenic Bladder, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Storage (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.