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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD080205 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. Locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. In addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.
Objectives: To determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity-based locomotor training | Experimental | To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions. |
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| Activity-based stand training | Experimental | To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions. |
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| Activity-based upper arm ergometry | Experimental | To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions. |
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| Activity based training + spinal epidural stimulation | Experimental | combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity-based locomotor training | Procedure | The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066). |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder Storage | Bladder capacity (mlH2O) | 5 years, 2 months |
| Bladder Emptying | Voiding Efficiency (% voided) | 5 years, 2 months |
| Bladder Pressure | Leak point pressure (cmH2O) | 5 years, 2 months |
| Compliance | Bladder Compliance (ml/cmH2O) | 5 years, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function (IIEF) | There are 5 domains to the International Index of Erectile Function questionnaire: erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Scoring 1-7: severe erectile dysfunction (ED), 8-11: Moderate ED, 12-16: mild-moderate ED, 17-21 mild ED, 22-25: no ED. Higher values represent better outcomes. Overall IIEF score range is 5-75; total >61.8 considered normal. |
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Criteria: Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Nitkin, PhD | National Institutes of Health (NIH) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278365 | Derived | Hubscher CH, Wyles J, Gallahar A, Johnson K, Willhite A, Harkema SJ, Herrity AN. Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. Arch Phys Med Rehabil. 2021 May;102(5):865-873. doi: 10.1016/j.apmr.2020.11.002. Epub 2020 Dec 3. | |
| 29385166 | Derived | Hubscher CH, Herrity AN, Williams CS, Montgomery LR, Willhite AM, Angeli CA, Harkema SJ. Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One. 2018 Jan 31;13(1):e0190998. doi: 10.1371/journal.pone.0190998. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Activity-based Locomotor Training | To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions. Activity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066). |
| FG001 | Activity-based Stand Training | To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions. Activity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study. |
| FG002 | Activity-based Upper Arm Ergometry | To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions. Activity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study. |
| FG003 | Activity-based Training + Spinal Epidural Stimulation | combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Activity-based Locomotor Training | To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions. Activity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bladder Storage | Bladder capacity (mlH2O) | Posted | Mean | Standard Deviation | mLH2O | 5 years, 2 months |
|
5 years, 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Activity-based Locomotor Training | To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions. Activity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Hand Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Hubscher | University of Louisville | 502-852-3058 | charles.hubscher@louisville.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2017 | Oct 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Activity-based stand training | Procedure | The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study. |
|
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| Activity-based upper arm ergometry | Procedure | The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study. |
|
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| Activity-based training + spinal epidural stimulation | Procedure | combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand. |
|
| 5 years, 2 months |
| BG001 | Activity-based Stand Training | To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions. Activity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study. |
| BG002 | Activity-based Upper Arm Ergometry | To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions. Activity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study. |
| BG003 | Activity-based Training + Spinal Epidural Stimulation | To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions. Activity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study. |
| OG002 | Activity-based Upper Arm Ergometry | To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions. Activity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study. |
| OG003 | Activity-based Training With Spinal Epidural Stimulation | To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand. |
|
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| Primary | Bladder Emptying | Voiding Efficiency (% voided) | Posted | Mean | Standard Deviation | % Void Efficiency | 5 years, 2 months |
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|
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| Primary | Bladder Pressure | Leak point pressure (cmH2O) | Posted | Mean | Standard Deviation | cm H2O | 5 years, 2 months |
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| Primary | Compliance | Bladder Compliance (ml/cmH2O) | Posted | Mean | Standard Deviation | mL/cmH2O | 5 years, 2 months |
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| Secondary | International Index of Erectile Function (IIEF) | There are 5 domains to the International Index of Erectile Function questionnaire: erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Scoring 1-7: severe erectile dysfunction (ED), 8-11: Moderate ED, 12-16: mild-moderate ED, 17-21 mild ED, 22-25: no ED. Higher values represent better outcomes. Overall IIEF score range is 5-75; total >61.8 considered normal. | Male data only (insufficient N for females) | Posted | Mean | Standard Error | score on a scale | 5 years, 2 months |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Activity-based Stand Training | To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions. Activity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Activity-based Upper Arm Ergometry | To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions. Activity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study. | 0 | 10 | 1 | 10 | 1 | 10 |
| EG003 | Activity Based Training + Spinal Epidural Stimulation. | Combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014947 | Wounds and Injuries |