Trial Outcomes & Findings for Recovery of Bladder and Sexual Function After Spinal Cord Injury (NCT NCT03036527)
NCT ID: NCT03036527
Last Updated: 2024-06-13
Results Overview
Bladder capacity (mlH2O)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
5 years, 2 months
Results posted on
2024-06-13
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
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.
|
Activity-based Training + Spinal Epidural Stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
12
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Recovery of Bladder and Sexual Function After Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Activity-based Locomotor Training
n=8 Participants
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).
|
Activity-based Stand Training
n=12 Participants
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.
|
Activity-based Upper Arm Ergometry
n=10 Participants
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.
|
Activity-based Training + Spinal Epidural Stimulation
n=10 Participants
To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.4 years
n=93 Participants
|
33.75 years
n=4 Participants
|
31.3 years
n=27 Participants
|
28.6 years
n=483 Participants
|
30.8 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
12 participants
n=4 Participants
|
10 participants
n=27 Participants
|
10 participants
n=483 Participants
|
40 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 5 years, 2 monthsBladder capacity (mlH2O)
Outcome measures
| Measure |
Activity-based Locomotor Training
n=8 Participants
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).
|
Activity-based Stand Training
n=12 Participants
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.
|
Activity-based Upper Arm Ergometry
n=10 Participants
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.
|
Activity-based Training With Spinal Epidural Stimulation
n=10 Participants
To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
Bladder Storage
|
278.5 mLH2O
Standard Deviation 147.8
|
447.75 mLH2O
Standard Deviation 278.9
|
580.5 mLH2O
Standard Deviation 313.2
|
313.0 mLH2O
Standard Deviation 166
|
PRIMARY outcome
Timeframe: 5 years, 2 monthsVoiding Efficiency (% voided)
Outcome measures
| Measure |
Activity-based Locomotor Training
n=8 Participants
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).
|
Activity-based Stand Training
n=12 Participants
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.
|
Activity-based Upper Arm Ergometry
n=10 Participants
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.
|
Activity-based Training With Spinal Epidural Stimulation
n=10 Participants
To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
Bladder Emptying
|
63.9 % Void Efficiency
Standard Deviation 8.9
|
6.2 % Void Efficiency
Standard Deviation 13.0
|
12.8 % Void Efficiency
Standard Deviation 19.8
|
28.0 % Void Efficiency
Standard Deviation 33.0
|
PRIMARY outcome
Timeframe: 5 years, 2 monthsLeak point pressure (cmH2O)
Outcome measures
| Measure |
Activity-based Locomotor Training
n=8 Participants
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).
|
Activity-based Stand Training
n=12 Participants
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.
|
Activity-based Upper Arm Ergometry
n=10 Participants
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.
|
Activity-based Training With Spinal Epidural Stimulation
n=10 Participants
To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
Bladder Pressure
|
42.7 cm H2O
Standard Deviation 18.6
|
33.75 cm H2O
Standard Deviation 22.7
|
45 cm H2O
Standard Deviation 36.2
|
29.0 cm H2O
Standard Deviation 20.0
|
PRIMARY outcome
Timeframe: 5 years, 2 monthsBladder Compliance (ml/cmH2O)
Outcome measures
| Measure |
Activity-based Locomotor Training
n=8 Participants
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).
|
Activity-based Stand Training
n=12 Participants
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.
|
Activity-based Upper Arm Ergometry
n=10 Participants
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.
|
Activity-based Training With Spinal Epidural Stimulation
n=10 Participants
To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
Compliance
|
15.5 mL/cmH2O
Standard Deviation 16.8
|
33.8 mL/cmH2O
Standard Deviation 12.5
|
17.0 mL/cmH2O
Standard Deviation 5.8
|
20.0 mL/cmH2O
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: 5 years, 2 monthsPopulation: Male data only (insufficient N for females)
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.
Outcome measures
| Measure |
Activity-based Locomotor Training
n=5 Participants
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).
|
Activity-based Stand Training
n=11 Participants
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.
|
Activity-based Upper Arm Ergometry
n=9 Participants
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.
|
Activity-based Training With Spinal Epidural Stimulation
n=8 Participants
To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
International Index of Erectile Function (IIEF)
|
20.8 score on a scale
Standard Error 4.3
|
26.4 score on a scale
Standard Error 5.7
|
30.0 score on a scale
Standard Error 8.8
|
29.7 score on a scale
Standard Error 7.6
|
Adverse Events
Activity-based Locomotor Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Activity-based Stand Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Activity-based Upper Arm Ergometry
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Activity Based Training + Spinal Epidural Stimulation.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Activity-based Locomotor Training
n=8 participants at risk
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).
|
Activity-based Stand Training
n=12 participants at risk
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.
|
Activity-based Upper Arm Ergometry
n=10 participants at risk
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.
|
Activity Based Training + Spinal Epidural Stimulation.
n=10 participants at risk
Combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/8 • 5 years, 2 months
|
0.00%
0/12 • 5 years, 2 months
|
10.0%
1/10 • Number of events 1 • 5 years, 2 months
|
0.00%
0/10 • 5 years, 2 months
|
Other adverse events
| Measure |
Activity-based Locomotor Training
n=8 participants at risk
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).
|
Activity-based Stand Training
n=12 participants at risk
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.
|
Activity-based Upper Arm Ergometry
n=10 participants at risk
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.
|
Activity Based Training + Spinal Epidural Stimulation.
n=10 participants at risk
Combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Left Hand Swelling
|
0.00%
0/8 • 5 years, 2 months
|
0.00%
0/12 • 5 years, 2 months
|
10.0%
1/10 • Number of events 1 • 5 years, 2 months
|
0.00%
0/10 • 5 years, 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place