Spinal Cord Injuries
Conditions
Keywords
Bladder, Sexual Function
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREActivity-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).
PROCEDUREActivity-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.
PROCEDUREActivity-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.
PROCEDUREActivity-based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Louisville
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Criteria: Inclusion Criteria: * stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training * no painful musculoskeletal dysfunction, * unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training * no clinically significant depression or ongoing drug abuse; * clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation * non- progressive suprasacral spinal cord injury * bladder and sexual dysfunction as a result of spinal cord injury
Exclusion criteria
* unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training; * painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training * clinically significant depression or ongoing drug abuse; * clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation * progressive spinal cord injury * no bladder and sexual dysfunction as a result of spinal cord injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder Storage | 5 years, 2 months | Bladder capacity (mlH2O) |
| Bladder Emptying | 5 years, 2 months | Voiding Efficiency (% voided) |
| Bladder Pressure | 5 years, 2 months | Leak point pressure (cmH2O) |
| Compliance | 5 years, 2 months | Bladder Compliance (ml/cmH2O) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF) | 5 years, 2 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 8 |
| 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. | 12 |
| 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. | 10 |
| 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. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Activity-based Locomotor Training | Activity-based Stand Training | Activity-based Upper Arm Ergometry | Activity-based Training + Spinal Epidural Stimulation |
|---|---|---|---|---|---|
| Age, Continuous | 30.8 years | 27.4 years | 33.75 years | 31.3 years | 28.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 8 Participants | 12 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants | 6 Participants | 10 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 10 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 40 participants | 8 participants | 12 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 33 Participants | 5 Participants | 11 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 12 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 8 | 0 / 12 | 1 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 12 | 1 / 10 | 0 / 10 |
Outcome results
Primary
Bladder Emptying
Voiding Efficiency (% voided)
Time frame: 5 years, 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity-based Locomotor Training | Bladder Emptying | 63.9 % Void Efficiency | Standard Deviation 8.9 |
| Activity-based Stand Training | Bladder Emptying | 6.2 % Void Efficiency | Standard Deviation 13 |
| Activity-based Upper Arm Ergometry | Bladder Emptying | 12.8 % Void Efficiency | Standard Deviation 19.8 |
| Activity-based Training With Spinal Epidural Stimulation | Bladder Emptying | 28.0 % Void Efficiency | Standard Deviation 33 |
Primary
Bladder Pressure
Leak point pressure (cmH2O)
Time frame: 5 years, 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity-based Locomotor Training | Bladder Pressure | 42.7 cm H2O | Standard Deviation 18.6 |
| Activity-based Stand Training | Bladder Pressure | 33.75 cm H2O | Standard Deviation 22.7 |
| Activity-based Upper Arm Ergometry | Bladder Pressure | 45 cm H2O | Standard Deviation 36.2 |
| Activity-based Training With Spinal Epidural Stimulation | Bladder Pressure | 29.0 cm H2O | Standard Deviation 20 |
Primary
Bladder Storage
Bladder capacity (mlH2O)
Time frame: 5 years, 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity-based Locomotor Training | Bladder Storage | 278.5 mLH2O | Standard Deviation 147.8 |
| Activity-based Stand Training | Bladder Storage | 447.75 mLH2O | Standard Deviation 278.9 |
| Activity-based Upper Arm Ergometry | Bladder Storage | 580.5 mLH2O | Standard Deviation 313.2 |
| Activity-based Training With Spinal Epidural Stimulation | Bladder Storage | 313.0 mLH2O | Standard Deviation 166 |
Primary
Compliance
Bladder Compliance (ml/cmH2O)
Time frame: 5 years, 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity-based Locomotor Training | Compliance | 15.5 mL/cmH2O | Standard Deviation 16.8 |
| Activity-based Stand Training | Compliance | 33.8 mL/cmH2O | Standard Deviation 12.5 |
| Activity-based Upper Arm Ergometry | Compliance | 17.0 mL/cmH2O | Standard Deviation 5.8 |
| Activity-based Training With Spinal Epidural Stimulation | Compliance | 20.0 mL/cmH2O | Standard Deviation 25 |
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.
Time frame: 5 years, 2 months
Population: Male data only (insufficient N for females)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity-based Locomotor Training | International Index of Erectile Function (IIEF) | 20.8 score on a scale | Standard Error 4.3 |
| Activity-based Stand Training | International Index of Erectile Function (IIEF) | 26.4 score on a scale | Standard Error 5.7 |
| Activity-based Upper Arm Ergometry | International Index of Erectile Function (IIEF) | 30.0 score on a scale | Standard Error 8.8 |
| Activity-based Training With Spinal Epidural Stimulation | International Index of Erectile Function (IIEF) | 29.7 score on a scale | Standard Error 7.6 |